GMP Training and Implementation Tips

GMP Tips - We've moved!

2009-01-13T09:21:00.001-08:00

Our blog, GMP Training and Implementation Tips, has moved!

Go to www.gmptrainingsystems.com/GMPtips

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1533 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/web-seminars

Effective GMP Auditing: Skills to Audit Manufacturing, Laboratories, and Suppliers
Jan 23, Feb 6, 13, 20

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

Cleaning Validation Boot Camp
March 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - New Process Validation Guideline

2009-01-05T10:11:00.001-08:00

FDA recently issued a draft of an updated Guidance Document for Process Validation: General Principles and Practices. The deadline for submitting comments to FDA is January 17, 2009. Get a copy of this draft guidance. Go to:

www.gmptrainingsystems.com/resources
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1532 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/web-seminars

Effective GMP Auditing: Skills to Audit Manufacturing, Laboratories, and Suppliers
Jan 23, Feb 6, 13, 20

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

Cleaning Validation Boot Camp
March 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - Brain Food, Wizard Oil, and other Nostrums - Dec 16, 2008

2008-12-16T14:00:00.000-08:00

A nostrum is a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.

We've compiled a few graphics of nostrums from the early 1900's. You may find them useful when preparing your GMP training materials.

To get your FREE copy of these graphics, go to
www.gmptrainingsystems.com/resources
Click on Timely Resource Articles and scroll down.
Note: These graphics have all been obtained from FDA's web site.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1529 clients since 1996

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

Cleaning Validation Boot Camp
March 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - Drug GMP Amendments Effective Dec 8, 2008

2008-12-08T17:33:00.000-08:00

The new Amendments to the Drug cGMP go into effect on Monday, December 8, 2008.

Get a copy of these Amendments.
www.gmptrainingsystems.com/resources
Select FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1527 clients since 1996

Upcoming workshops - 2009
www.gmptrainingsystems.com/public-workshops

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMPTips - Congressional report condemns FDA - Nov 18, 2008

2008-11-18T12:17:00.000-08:00

The U.S. Government Accountability Office (GAO), the investigative arm of Congress, recently issued a report condemning FDA’s ability to monitor foreign drug manufacturers. The GAO said the FDA has faulty records on the facilities it oversees because it doesn't require companies to update information such as corporate names and addresses annually. "FDA does not know the number of establishments subject to inspection," the report says. Currently, domestic companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years.

The report "confirms that the system deployed by FDA to police (foreign) facilities and keep Americans safe from poorly manufactured drugs is understaffed, overwhelmed and completely inadequate," said Rep. Bart Stupak, D-Mich.

Read two news accounts and the GAO report. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1521 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Nov 25 Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

Dec 8 Fundamentals of HPLC web course

Upcoming workshops - 2009
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - FDA Sends in U.S. marshals to seize contaminated heparin - Nov 10, 2008

2008-11-10T12:55:00.000-08:00

Frustrated after twice asking Cincinnati-based Celsus Laboratories, Inc. to recall contaminated heparin, the FDA sent in U.S. marshals to seize 11 lots of the blood-thinning drug.

Read two articles with details here.
www.gmptrainingsystems.com/asp/resources.asp
Select Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1519 clients since 1996

Upcoming web seminars
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Nov 14 New Revisions to Drug GMP: What You Must do to Comply

Nov 25 Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

Upcoming workshops - 2009
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - Obama and the FDA - Nov 6, 2008

2008-11-06T13:59:00.000-08:00

Yesterday we predicted the FDA would be strengthened under an Obama presidency. We're already seeing evidence begin to surface. Here's a headline from today, Nov 6. Obama Expected to Bolster FDA Oversight of Imports

Here's an excerpt: The FDA, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration.

With President Bush no longer a roadblock, health officials also can expect new powers to control tobacco, from cigarettes to the recently introduced smokeless products called snus.

President-elect Obama, a former smoker struggling to avoid relapse, is a sponsor of legislation giving the FDA authority to control, but not ban, tobacco and nicotine.

Read the entire article. Go to:
www.gmptrainingsystems.com/asp/resources.asp

Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1515 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - FDA in the New Administration - Nov 5, 2008

2008-11-05T08:33:00.000-08:00

Now that the Democratic party will have control over Congress and the Presidency, can we expect a strengthened FDA?

The Democrats tend to favor more regulation. We predict that Congress will provide more funding for the FDA and that the new President will nominate a new Commissioner - one that will emphasize more frequent and stricter inspections.

Now is the time to prepare! Schedule internal audits! Schedule GMP training! Be proactive!

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1515 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - How to Keep Your Job in Today's Economy – Oct 27, 2008

2008-10-27T13:01:00.000-07:00

With the grim economic news these days, we decided to do something special for our clients and readers. We have created a special audio seminar - Managing Your Career in a Down Economy: How to Save Your Job and Survive a Corporate Downsizing

The seminar is scheduled for November 6 at 8:00 pm EST and we made sure it is at an affordable price - only $29.95! A small investment to ensure the success of your career.

For a full description and to register, go to:
http://gmptrainingsystems.com/asp/gmp_store_081106.asp

This seminar will be conducted by David Markovitz, President of GMP Training Systems. David's career spans over three decades. He started his corporate career during the Watergate turmoil when inflation ran rampant. He survived the recession in the early 1980's and the stock market crash of 1987. He successfully grew his career while working for four major corporations before starting his own company in 1996. His business actually grew after the September 2001 attacks and market downturn and is thriving today.

And on November 25, David will conduct a seminar for Managers and Supervisors - Managing Your Staff in a Down Economy: How to Keep Your People Focused and Productive

For a full description and to register, go to:
http://gmptrainingsystems.com/asp/gmp_store_081125.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1511 clients since 1996

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - Make GMP Personal Part 3 - Oct 20, 2008

2008-10-20T13:31:00.000-07:00

David Markovitz, President of GMP Training Systems, Inc., here with a Thank You for the work you do. Here's our story.

Two weeks ago my wife's ear lobes got infected from a new pair of earrings. (Maybe they were manufactured in China.) She went to the Doc and got a prescription for an antibiotic. A few days later the infection spread to her left eye. An antibiotic eye drop was then prescribed. A few days after that the entire side of her face swelled up within hours. An emergency visit to her Doc got her admitted to the hospital where she spent two days and received antibiotics via IV line. (The last time she was hospitalized was 26 years ago when our daughter was born.) The antibiotics worked like magic and she was released on Oct 18 and looks about 95% back to normal today (Oct 20).

Yes, what we do is very personal. So thanks go out from our family to those who manufacture drug products and medical device products and follow GMP every day.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1507 clients since 1996

Effective Auditing Skills web seminar series starts Oct 22
A comprehensive course delivered "in your office" as eight one-hour web seminars.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - Ranbaxy's Continuing Woes, and What We Can Learn from Them - Oct 14, 2008

2008-10-14T12:09:00.000-07:00

You may have been watching the continuing saga of one of the worlds largest providers of generic drugs, Ranbaxy Laboratories, based in India, and their problems meeting US FDA’s GMP requirements. FDA has been in discussions with Ranbaxy Laboratories for several months concerning two facilities. After much discussion and what it deemed inadequate responses from the drugmaker, the FDA decided to issue the two Warning Letters and to encourage the confiscation of products coming from the two facilities into the United States.

Read the two Warning Letters. Also read an article from Forbes and a news account from a publication in India. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resources Articles and scroll down.

GMP Training Tip
Use information from these Warning Letters to make your GMP training sessions come alive and relevant. Learning from OPE, Other People's Experience, is a good and easy way to keep your company in a healthy compliance mode.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1503 clients since 1996

Effective Auditing Skills web seminar series starts Oct 22
A comprehensive course delivered "in your office" as eight one-hour web seminars.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA Seats still available!

2009
GMP Boot Camp: Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Validation Boot Camp
Feb 25 - 26 Philadelphia, PA

GMP Boot Camp: Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - New FDA Training Resource - Oct 7, 2008

2008-10-07T12:01:00.000-07:00

FDA just added a new training resource to their website - CDRH Learn - for the Medical Device industry. There are two on-line courses conducted by FDA staff. They contain video of the speaker and PowerPoint slides to follow along.

One of the courses is a Basic Introduction to the Quality System Regulation 21CFR Part 820.

Take a look - go to: http://www.fda.gov/cdrh/cdrhlearn

These courses may give you ideas and material to enhance your GMP training efforts.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1497 clients since 1996

Web seminars October schedule
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of Validation
Oct 15 - 16 Philadelphia, PA Seats still available

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA

2009
Fundamentals of GMP/QSR
Feb 18 - 19 Anaheim, CA

Fundamentals of GMP/QSR
Apr 22 - 23 Alexandria, VA

Please forward this to others in your organization who may benefit.

GMP Tips - Make GMP Personal Part 2 - Sept 30, 2008

2008-09-30T14:22:00.000-07:00

David Markovitz, President of GMP Training Systems, Inc. here with a personal GMP Tip.

One proven method for getting GMP training to STICK is to make it personal. When I conduct GMP training sessions for client companies, I always start with a slide of me and my family. I usually have a little fun with it by pointing out that I am the only KNOWN drug user in my family. I explain that I take a prescription drug to lower my cholesterol, which, thanks to my mother’s side of the family, is genetically on the high side of normal.

I point out that the FDA regulated industries manufacture and distribute products that affect people personally. Everyone in each training session knows someone close to them whose life has either been lengthened, improved, or even saved – thanks to what we do. Reaching people at this emotional level sets people up for paying closer attention during the training session.

My approach to compliance is from the customers’ perspective. We strive to produce quality products because that’s what our customers expect. I also point out that the FDA works for our customers. Our customers rely upon the FDA to ensure that we operate in accordance to the Good Manufacturing Practice.

So we follow GMP because we want to have satisfied and happy customers. That’s a far better way to explain it than “We follow GMP because FDA says so!”

Our customers – citizens and taxpayers – have given FDA authority through Congress to enforce GMP and other regulations. But never forget that the ultimate judge of the success of our company is in the hands of our customers.

Make your GMP training personal to increase your effectiveness.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1493 clients since 1996

Web seminars October schedule
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR
Oct 8 - 9 Anaheim, CA Seats still available

Fundamentals of Validation
Oct 15 - 16 Philadelphia, PA Seats still available

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA

Please forward this to others in your organization who may benefit.

GMP Tips - Make GMP Personal - Sept 21, 2008

2008-09-21T06:21:00.000-07:00

Recently we conducted on-site GMP training for a company that manufactures drugs for animals. One thing we observed while in the facility was the pictures of people with their pets hanging in all the hallways. It was pointed out to us that these pictures were of the employees with their pets.

What a great way to make GMP personal - a reminder to everyone every day that they are their own customers. Making GMP a Lifestyle is the key to success.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1488 clients since 1996

Web seminars October schedule
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR
Oct 8 - 9 Anaheim, CA

Fundamentals of Validation
Oct 15 - 16 Philadelphia, PA

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA

Please forward this to others in your organization who may benefit.

GMP Tips - FDA Revises Drug GMP - Sept 15, 2008

2008-09-15T08:56:00.000-07:00

Last week FDA issued a Final Rule titled “Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.” The rule revises CGMP requirements primarily for aseptic processing, the use of asbestos filters, and the verification of performance operations by a second individual. This Amendment is scheduled to go into effect on December 8, 2008.

Download a copy of the Amendments. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1484 clients since 1996

Web seminars start up again on Sept 19
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR
Oct 8 - 9 Anaheim, CA

Fundamentals of Validation
Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico

GMP for Dietary Supplements 21CFR Part 111
Nov 12 - 13 Anaheim, CA

Please forward this to others in your organization who may benefit.

GMP Tips - GMP: Great Mounds of Paper? - Sept 9, 2008

2008-09-09T16:15:00.000-07:00

Imagine a quiz question at one of your GMP training sessions.

GMP stands for:
A. Get More Production
B. Good Manufacturing Practice
C. Get More Pizza
D. Great Mounds of Paper

If someone answered D, Great Mounds of Paper, could they argue for at least partial credit?

We think so - and we use this question as a lead-in to discussing the importance of paperwork, or documentation in our GMP training sessions.

What other interesting and fun ways do you use to make points in your GMP training sessions?

Send us your Tips and we'll publish a compilation for all to see. Send them to support@gmptrainingsystems.com

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1479 clients since 1996

Web seminars start up again on Sept 19
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR
Oct 8 - 9 Anaheim, CA

GMP Tips - The "c" in cGMP - Sept 2, 2008

2008-09-02T12:33:00.000-07:00

The "c" in cGMP stands for current. One way to stay current is to review presentations by FDA people at various meetings and conferences. One we found interesting addresses Quality Program, CAPA, and Audits. You can download a copy and read it yourself.

Go to: www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1473 clients since 1996

Web seminars start up again on Sept 11
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico

Please forward this to others in your organization who may benefit.

GMP Tips - Avoiding Recalls - August 18, 2008

2008-08-18T14:27:00.000-07:00

Actavis Totowa LLC just announced a voluntary recall of all drug products manufactured at its Little Falls, New Jersey, facility. This is a voluntary action following an inspection conducted by the US Food and Drug Administration earlier this year. Approximately 55 products are being recalled.

According to a statement from the company, “The inspection at Little Falls revealed operations that did not meet the FDA’s or Actavis’ standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.”

The current recall is the third recall by the company this year. In April, Actavis Totowa initiated voluntary recall of “Digitek” (digoxin tablets, USP, all strengths) for oral use. That recall was due to the possibility that tablets with double the appropriate thickness may have been commercially released and that the tablets may have contained twice the approved level of active ingredient.

In March, Actavis’ subsidiary Actavis South Atlantic LLC recalled fentanyl transdermal system CII patches sold in the United States. The recalled patches were manufactured by Corium International (Menlo Park, CA), a contract manufacturer for Actavis. The fentanyl transdermal system patches recalled may have had a fold-over defect that has the potential to cause the patch to leak fentanyl gel. As a precaution, Actavis recalled the products.

GMP Training Tip

Use this example in your GMP training sessions. If you produce tablets, ask the question, “How could they have produced, tested, approved, and shipped tablets that were DOUBLE the appropriate thickness?" and discuss answers.

Discuss the impact of recalling 55 products. How will this affect the company, the workers, their reputation, their future sales?

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1468 clients since 1996

Big summer savings! Available during August only.
Call us at 714-289-1233 to take advantage of these fantastic savings!

GMP Training System (Instructor-led version)
Ideal for new employees, temps, contractors, and for annual refresher training.

Option One - English version $4200 reduced to $3600 during August only.

Option Two - Buy the English version and get the Spanish version for 50% off. A savings of $2,100.00!!!!!!!

FDA Survival Kits
Buy one of our Survival Kits and get one hour telephone consultation with the developer/author absolutely FREE. A $500 value!!!!!

Web seminars
Buy three of our archived web seminars, and get the fourth one FREE! You get the MP3 file (or CD) of the audio program and all handout files for each program. A savings of $397.00!!!!!!

Upcoming workshops
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico

Please forward this to others in your organization who may benefit.

GMP Tips - New Employee Orientation - Aug 11, 2008

2008-08-11T10:59:00.000-07:00

Your best chance to ensure compliance with GMP from your people is to give them their first dose of GMP training during their New Employee Orientation. The basic message at the start is to make sure that everyone knows that they are working in a regulated industry, and following procedures is first and foremost critically important in this environment.

People may be joining your company from places where they are free to make changes (improvements) where and when they see fit - without documentation. The FDA regulated industries are different - changes must flow through a formal Change Control process and must be documented.

GMP Tip
These are two points you want to drive home at the very start of someone's tenure with your company.

Follow procedures, and if for whatever reason you cannot, stop and alert your supervisor.
Any change to a process must be reviewed and approved before it can be implemented.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1465 clients since 1996

Big summer savings! Available during August only

GMP Training System (Instructor-led version)
Buy the English version and get the Spanish version for 50% off. A savings of $2,100.00!!!!!!! Ideal for new employees, temps, contractors, and for annual refresher training.

FDA Survival Kits
Buy one of our Survival Kits and get one hour telephone consultation with the developer/author absolutely FREE. A $500 value!!!!!

Web seminars
Buy three of our archived web seminars, and get the fourth one FREE! You get the MP3 file (or CD) of the audio program and all handout files for each program. A savings of $397.00!!!!!!

Call us at 714-289-1233 to take advantage of these fantastic savings!

Upcoming workshops

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Effective Response to FDA 483 - August 6, 2008

2008-08-06T12:02:00.000-07:00

Just last week a Warning Letter was issued to NeoChild LLC. In this Warning Letter FDA takes issue with several of the company's responses to the the FDA 483, List of Inspectional Observations, that they received during an FDA inspection.

This particular Warning Letter provides very specific insights into FDA's current thinking and outlines their expectations on specific issues. We recommend that you share this Warning Letter with those in your company responsible for dealing directly with the FDA during inspections.

GMP Tip
Use this letter and other Warning Letters in your GMP training to discuss specific GMP issues and whether your company may be vulnerable. Learning from other people's experiences with FDA can keep you out of trouble with the FDA.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1463 clients since 1996

Big summer savings! Available in August only

GMP Training System (Instructor-led version)
Buy the English version and get the Spanish version for 50% off. A savings of $2,100.00!!!!!!!

FDA Survival Kits
Buy one of our Survival Kits and get one hour telephone consultation with the developer/author absolutely FREE. A $500 value!!!!!

Web seminars
Buy three of our archived web seminars, and get the fourth one FREE! You get the MP3 file (or CD) of the audio program and all handout files for each program. A savings of $397.00!!!!!!

Call us at 714-289-1233 to take advantage of these fantastic savings!

Upcoming workshops

Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA

Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this to others in your organization who may benefit.

GMP Tips - caPA and Design Control - July 28, 2008

2008-07-28T12:36:00.000-07:00

Recently three companies manufacturing medical devices received Warning Letters from the FDA. A large focus was on caPA (Corrective and Preventive Action) and Design Control.

One way to remain "current" with the GMP and QSR regulations is to read Warning Letters issued by FDA. Read these three Warning Letters.

Go to: www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1459 clients since 1996

New for 2008! Two new Survival Kits

Survival Kit for Regulatory Inspections
Validation Survival Kit
Statistics Survival Kit coming soon

www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this to others in your organization who may benefit.

GMP Tips - The Last Lecture - July 28, 2008

2008-07-28T09:46:00.000-07:00

This post is different than usual. Today we focus on an extraordinary professor at Carnegie-Mellon University. Last year this Professor of Computer Science, Randy Pausch, was diagnosed with pancreatic cancer. He died on July 25, 2008.

Carnegie Mellon has a tradition of asking speakers at their lecture series to address one age-old question: "What would you say if you knew you were going to die and had a chance to sum up everything that was most important to you?"

For Randy Pausch, this was not a hypothetical question. Married with three young children and in the midst of an astonishing career working with virtual reality, he had everything to lose. Yet his lecture is one of the most inspiring speeches you'll ever hear.

His remarkable speech has been captured and is among the most viewed videos on the internet. It is a powerful story of hope, grace, and optimism. Randy's words will definitely cause you to examine your life and career. To see it, go to www.thelastlecture.com

ABC will devote its program Primetime to Randy on Tuesday, July 29 at 10 pm EDT.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1459 clients since 1996

New for 2008! Two new Survival Kits

Survival Kit for Regulatory Inspections
Validation Survival Kit
Statistics Survival Kit coming soon

www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Mandela's Leadership Lessons - July 21, 2008

2008-07-21T14:33:00.000-07:00

Last week marked Nelson Mandela's 90th birthday. Time ran an excellent story summarizing his Eight Lessons of Leadership. We found this to be worthy of adding to our Leadership library.

To read this article, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1457 clients since 1996

New for 2008! Two new Survival Kits

Survival Kit for Regulatory Inspections
Validation Survival Kit

www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA

Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Keep Your GMP Awareness HIGH – July 15, 2008

2008-07-15T07:49:00.000-07:00

One of the best ways we’ve seen companies keep GMP awareness high throughout their company is by posting pictures of their customers in prominent places. We’ve even seen billboard size posters of smiling customers hanging on the exterior of buildings.

Usually the picture is accompanied by a theme – one theme we saw that we particularly liked was “Our Measure of Success.” Ah, our Measure of Success is that our customers are still alive and enjoying a good quality of life thanks to the work we do.

Hallways, training rooms, conference rooms, lunch rooms and cafeterias are good places to put these. Make sure they are located where employees enter the building. A daily reminder of how important our customers are goes a long way in instilling pride in our workers. And when people have a sense of pride in their work, they tend to be more careful and vigilant.

We recently conducted training for a company that manufactures drugs for animals. They have photos of their employees with their pets in the hallways throughout the facility. Those who work there are customers of their own products. And people get a thrill of seeing their own photo hanging in the plant. These beat generic “Do it Right!” posters any day of the week.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1453 clients since 1996

New for 2008! Two new Survival Kits
Survival Kit for Regulatory Inspections
Validation Survival Kit
www.gmptrainingsystems.com/asp/survival_kits.asp

Upcoming workshops
Fundamentals of GMP/QSR Oct 8 - 9 Anaheim, CA

Fundamentals of GLP Oct 8 Anaheim, CA
Implementing CAPA Effectively Oct 9 Anaheim, CA

Fundamentals of Validation Oct 15 - 16 Philadelphia, PA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

Please forward this to others in your organization who may benefit.

GMP Tips - GMP (FDA) and Safety (OSHA) - July 7, 2008

2008-07-07T09:51:00.000-07:00

In the US, every company is mandated by OSHA to conduct safety meetings on a regular basis. The focus of these meetings is on the safety of those working at the company.

GMP can also be viewed as a safety program - ensuring the safety of our customers.

GMP Training Tip
When you conduct a Safety Meeting, reserve an additional fifteen minutes or so at the end to conduct a GMP training session. Your people are already gathered together and focusing on safety. Shift the conversation to the safety of your customers and, voila, you are now in a GMP meeting. Document this training and you can fulfill FDA's requirement of conducting GMP training on an ongoing basis and with sufficient frequency to assure employees remain familiar with cGMP requirements.

Our GMP Training System is an ideal product for this purpose. Each of the twelve modules is designed to take about fifteen minutes to deliver. For more info, go to:
www.gmptrainingsystems.com/asp/gmp_training_system.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1449 clients since 1996

Upcoming workshops
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008! Two new Survival Kits
Survival Kit for Regulatory Inspections
Validation Survival Kit
www.gmptrainingsystems.com/asp/survival_kits.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Effective Written Procedures - June 30, 2008

2008-06-30T15:46:00.000-07:00

Writing written procedures that are EFFECTIVE is not a simple task. The best way we've seen to ensure that your written procedures are mutually understood and followed is to involve several people when writing and reviewing them. Always include one or more Subject Matter Experts (SMEs). Always include someone from your Quality group. Always include several people from the group who will be using that procedure.

Does it take longer to produce a written procedure this way? YES.

But consider two things.
1. You'll get a better procedure - one far less prone to be misunderstood.
2. Those using the procedure will have some sense of ownership - they will refer to the procedures as OUR procedures. People are far less likely to ignore their own procedures.

How much time is spent in your company resolving issues where a written procedure wasn't followed as written? I guarantee it's more time than you would have spent in writing an effective procedure in the first place.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1443 clients since 1996

Upcoming workshops
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

GMP Tips - Timely Tip on Written Procedures - June 24, 2008

2008-06-24T07:53:00.000-07:00

Preparing effective written procedures is always a challenge. We've discovered some facts about those entering the workforce this year that may make preparing good written procedures and conducting effective training even more challenging. Consider these facts:

The people who are entering the workplace or starting college this year were born in 1990.
They don’t remember the first President Bush.
They grew up with computers in the house.
They have always had cell phones and Voicemail.
They invented their own language to use with text messaging.

We've prepared an entire list for your review. To download a copy, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1438 clients since 1996

Upcoming workshops
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

GMP Tips - Keep your Training ALIVE! - June 15, 2008

2008-06-15T08:38:00.000-07:00

There are several ways to keep your GMP training ALIVE after a training session. Here’s one idea.

Create Table Toppers with a GMP reinforcement message that you can place on the tables in the lunch room or cafeteria. You can simply print these on heavy card stock and fold them in half and place them on the tables. A better solution is to purchase the clear plastic stands like restaurants use to display their specials and slip the Table Topper in them.

Printing these at 4” x 6” is a good size to catch peoples’ eyes and not be too obtrusive. Changing them every week is a good way to keep your GMP Training ALIVE!

For an example, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1433 clients since 1996

Upcoming workshops
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
Fundamentos de las Regulaciones de Buenas Practicas de Manufactura y Sistemas de Calidad
Oct 22 - 23 Mexico City, Mexico
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

GMP Tips - FDA Enforcement Shift & Staffing Crisis - June 9, 2008

2008-06-09T12:07:00.000-07:00

FLASH! FDA Warning Letters have dropped by half in the past ten years. And recalls have increased.

FLASH! The average age of an FDA staffer is 54, and thirty percent are already eligible for retirement.

And this week FDA is taking heat for the tomato salmonella outbreak (even McDonald's announced today that they will not use sliced tomatoes in their products).

Read more about the Warning Letter decline and the crisis in manpower at FDA. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

How might these issues affect us?
Expect more rigorous inspections. We've already seen longer FDA 483s issued to companies this year.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1433 clients since 1996

Upcoming workshops
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

GMP Tips - FDA & EMEA to Conduct Joint Inspections - June 2, 2008

2008-06-02T17:06:00.000-07:00

FDA and the European Medicines Agency (EMEA) will pilot a joint GMP inspections program under a bilateral agreement.

The joint inspections program will apply to facilities in both the U.S. and the European Union (EU). Joint inspections of active pharmaceutical ingredient (API) facilities in countries outside the U.S. and the EU will be part of the program as well.

The agencies will pilot a GMP information exchange covering inspection schedules and results. Information on facilities that have been inspected would be shared so the agencies could get greater inspection coverage and better identify API production sites in countries outside the U.S. and the EU.

“The collaboration on inspections should result in more effective use of resources and a higher safety level of product from third countries,” the EC said.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1429 clients since 1996

Upcoming workshops
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Laws Enforced by FDA - May 27, 2008

2008-05-27T10:10:00.000-07:00

FDA has compiled a list of all the laws and related statutes that they enforce. To see this list, go to:

www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1424 clients since 1996

Upcoming workshops
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Drug Company Shut Down by FDA - May 19, 2008

2008-05-19T13:08:00.001-07:00

FDA announced last week that Scientific Laboratories Inc. signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

Read FDA's Press Release. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Tip
Use information like this in your GMP trainings to reinforce the need to follow cGMP and related laws and regulations.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1417 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Tips - Customer Complaint Handling - May 12, 2008

2008-05-12T09:03:00.000-07:00

FDA recently issued a Warning Letter to National Biological Corporation citing deficiencies in handling customer complaints and following their own caPA (Corrective and Preventive Action) procedures. This particular Warning Letter gives us insights into what FDA expects in managing customer complaints for medical devices.

Read this Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1411 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Training - Merck gets Warning Letter - May 5, 2008

2008-05-05T09:29:00.000-07:00

Merck and Company, Inc. received a nine-page Warning Letter from FDA on April 28. In addition to citations for some of their drug products, they were also cited for cGMP deficiencies concerning bulk drug substances and drug components. Areas cited included Production and Process Controls, Failure Investigations, Laboratory Controls, Buildings and Facilities, Maintenance of Equipment, and Containers and Closures. This letter also contains FDA's reaction to Merck's responses to a previous FDA-483, Inspectional Observations, issued previously.

GMP Tip
Warning Letters give us insight into how the FDA thinks and what they are looking for. Use this and other Warning Letters in your GMP training sessions to reinforce the requirement to always follow cGMP and as an example of what could and does occur when FDA finds your company out of compliance.

Read this Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1407 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Training - FDA Perspective - Apr 29, 2008

2008-04-29T08:28:00.000-07:00

An article in the New England Journal of Medicine entitled Trying Times at the FDA — The Challenge of Ensuring the Safety of Imported Pharmaceuticals puts some perspective into the tough times FDA has been facing recently. An accompanying article, Playing “Kick the FDA” — Risk-free to Players but Hazardous to Public Health, sheds even more light on the situation.

Read both articles. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1401 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training System Now Available in English and Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

GMP Training - CAPA or caPA? - Apr 22, 2008

2008-04-22T10:51:00.000-07:00

We all know that CAPA stands for Corrective and Preventive Action. Here are two questions for you.

Where do you get the greatest payback for your investment - correcting problems or preventing problems?

Where do people in your company spend their time - mostly on correcting problems or mostly on preventing problems?

By simply using caPA instead of the traditional CAPA, you can send a message to your people on what's more important and where we should be investing our resources. Hint: Share this with your management too.

An article written by David Markovitz, President of GMP Training Systems, Inc. helps reinforce this notion. Go to:
www.gmptrainingsystems.com/asp/resources.asp

Scroll down to Articles authored by David Markovitz and find Problem Solving is Not Good Enough! Problem Prevention is the Key to Success.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1397 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

GMP Training - FDA withdraws GMP Changes - Apr 14, 2008

2008-04-14T10:08:00.000-07:00

The FDA withdrew a direct final rule that was published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations.

FDA is withdrawing the direct final rule because the agency received significant adverse comments. In their announcement, FDA said that it will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).

Stay tuned.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1391 clients since 1996

Upcoming workshops
Implementing GLP
June 5 San Francisco, CA
Implementing an Effective CAPA System
June 6 San Francisco, CA
GMP for Dietary Supplements
June 25 - 26 Anaheim, CA
Fundamentals of GMP/QSR
July 16 - 17 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

Use the Heparin Fiasco in Your GMP Training - Apr 10, 2008

2008-04-10T08:43:00.000-07:00

The FDA reported on April 9 that the death toll linked to contaminated heparin now stands at 62. Read a New York Times story dated April 10 with details. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip

Use this story in your GMP training sessions to reinforce the importance of following GMP. We always ask participants in our training the following question. “What’s the worst thing that could happen if you have a product failure once your product has been shipped?” Of course the answer is somebody could die, or someone could get hurt. This is a gut check for everyone involved in the FDA regulated industries. It’s not a bad thing to remind your people of the severe consequences of not following GMP.

FDA has set up a web page dedicated to this issue.

http://www.fda.gov/cder/drug/infopage/heparin/default.htm

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1389 clients since 1996

April 16 - 17 Anaheim, CA
Fundamentals of GMP Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
June 25 - 26 Anaheim, CA
GMPs for Dietary Supplements Boot Camp

GMP Training System Now Available in Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

FDA Cites Training Failures - Apr 2, 2008

2008-04-02T16:44:00.000-07:00

Training is an important element of GMP, and the FDA is not reluctant to cite a company for failures in this area. Here’s an actual citation from a Warning Letter issued in late February to a Medical Device manufacturer.

Failure to establish procedures for identifying training needs and for ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25(b). Your firm's training of operators was inadequate in that:

You have no document control of your operator training packet that consists of multiple, separate, non-sequentially numbered training documents.
Your operator training protocol is not linked to your written training procedures and has no document control to include management approval prior to implementation.
You do not have documentation of reviewing and approving an operator's training and testing records and results prior to the employee being released to receive medical alarm calls.

Read the entire Warning Letter issued to Philips Lifeline, Inc. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1384 clients since 1996

April 16 - 17 Anaheim, CA
Fundamentals of GMP Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
June 25 - 26 Anaheim, CA
GMPs for Dietary Supplements Boot Camp

GMP Training System Now Available in Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

FDA Website Gets New Look - Mar 24, 2008

2008-03-24T17:46:00.000-07:00

FDA has redesigned their website - www.FDA.gov.

Take a look and familiarize yourself with the new layout so that when you need something you'll already have a feel for the organization of the site.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1379 clients since 1996

Please forward this to others in your organization who may benefit.

Warning Letters due to Inadequate Response to FDA 483s Rising - Mar 17, 2008

2008-03-17T09:12:00.000-07:00

The number of Warning Letters issued because of an Inadequate Response to a FDA 483 continues to grow. One interesting Warning Letter, issued recently to Vintage Pharmaceuticals, LLC, points out the importance of good recordkeeping.

Read this letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Tip
Use Warning Letters like this one in your GMP training sessions to reinforce the importance of following cGMP as well as the requirement to follow procedures and document what is done when it's done.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1373 clients since 1996

April 16 - 17 Anaheim, CA
Fundamentals of GMP Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
June 25 - 26 Anaheim, CA
GMPs for Dietary Supplements Boot Camp

GMP Training System Now Available in Spanish
Three formats: Instructor-led system, Computer-based system, and Web-based system
www.gmptrainingsystems.com/asp/training_system_portal.asp

Please forward this to others in your organization who may benefit.

FDA at a Turning Point according to FDA Commissioner - Mar 10, 2008

2008-03-10T10:49:00.000-07:00

On February 29, 2008, FDA Commissioner Andrew C. von Eschenbach, M.D. gave a speech entitled “FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World.”

In his speech he outlined three main points.

How the world has rapidly and radically changed
Why these changes have brought FDA has to a turning point
And what is being done to re-create the FDA

Gain insights into today’s and tomorrow’s FDA.
Read this speech. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1368 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

FDA Under Fire in Congressional Testimony - March 4, 2008

2008-03-03T06:07:00.000-08:00

The FDA is suffering from a crisis in leadership, a lack of congressional oversight and a dangerous reliance on the pharmaceutical industry to bankroll its operations, Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen told a House of Representatives subcommittee on February 27.

“The situation at the FDA has never been worse than now,” Wolfe said. “Congress must act quickly to restore confidence in the FDA.”

On the same day, FDA’s Commissioner, Andrew von Eschenbach, challenged Congress on Friday to quickly give his agency more teeth to regulate food safety. "This is a time to not just be critical about what is not being done, but to collaborate on what must be done," von Eschenbach said in a speech at the National Press Club. "We can't transform this agency ourselves."

GMP Tip
More evidence that will likely result in FDA taking a tougher stand with industry. Be proactive – review your systems and processes, conduct an internal audit, and schedule GMP training.

Read Dr. Wolfe’s testimony. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1364 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

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FDA Mix-up & a Costly Lesson for Baxter - Feb 25, 2008

2008-02-25T08:57:00.000-08:00

Last week Baxter International, Inc. announced that it had temporarily suspended production of heparin because of about 350 reactions potentially tied to the drug, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery.

The Chinese factory (Baxter's supplier) involved in the production of possibly tainted blood-thinning drugs for export to America was not inspected by the U.S. FDA because of a paperwork error in which Washington regulators confused the factory's name with another that already had U.S. approval, the FDA said Monday.

An FDA spokeswoman said the plant making the active ingredient for the drug heparin "was supposed to be inspected" but "due to human error, and inadequate information technology systems, a pre-approval inspection, which would normally be conducted, was not."

Baxter CEO Robert Parkinson said he was unaware the Food and Drug Administration had not inspected a suspect supplier in China. "It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Parkinson said.

Note: Shouldn’t Baxter be conducting audits of their suppliers?

A Baxter spokeswoman confirmed that the company gets the active pharmaceutical ingredient for its heparin from a U.S. supplier that operates a plant in China. She said Baxter has been working with the U.S. supplier for 20 years, and the supplier has made the heparin ingredient for three decades. Baxter has only sold heparin since late 2002, when it bought a unit of Wyeth.

GMP Tip

Through an acquisition, Baxter picks up a new division to produce heparin. Supplier audits are an integral part of GMP. But somehow conducting a thorough inspection and audit of the supply chain for this product slipped through the corporate crack. And then it slips through a crack in FDA’s bureaucracy.

Next thing you know, 350 patient reactions and four deaths. Who wants to bet that Congress will be conducting more hearings about the competence of FDA?

Read the news story on how FDA “thought” they had inspected the plant when they inputted a company with a similar name into their database. Then read Baxter’s response to this fiasco. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1357 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

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Bad News for FDA Continues - Feb 18, 2008

2008-02-18T16:42:00.000-08:00

A key House Democrat said last week that the Commissioner of the FDA should resign in the wake of a probe over an antibiotic and news of a blood thinner linked to allergic reactions and four deaths.

"It's just a total lack of leadership," said Rep. Bart Stupak, D-Mich., chairman of the Subcommittee on Oversight and Investigations. He said he had lost confidence in the commissioner and other top FDA officials over the handling of inspections and oversight by the agency.

How does this affect us?
Expect stricter inspections and longer delays when dealing with FDA.

Details can be found in an AP news account. Read it here:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1353 clients since 1996

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.asp
April 16-70 Anaheim, CA
Fundamentals of GMP Boot Camp

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

Please forward this to others in your organization who may benefit.

The Bad News for FDA Continues - Feb 17, 2008

2008-02-16T10:40:00.000-08:00

A key House Democrat said last week that the Commissioner of the FDA should resign in the wake of a probe over an antibiotic and news of a blood thinner linked to allergic reactions and four deaths.

How does this affect us?
Expect stricter inspections and longer delays when dealing with FDA.

Details can be found in an AP news account. Read it here:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

New for 2008!
Survival Kit for Regulatory Inspections
http://snipurl.com/survival-kit

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Red Cross fined ... AGAIN! Feb 11, 2008

2008-02-11T12:56:00.000-08:00

FDA has fined the American Red Cross $4.6 million for the distribution of unsuitable blood products, brining penalties against the organization to more than $19 million in recent years.

The Red Cross' troubles with FDA date back over 17 years where they have committed "persistent and serious violations" of blood safety laws. Read a news account of FDA's latest action and the Red Cross' announcement. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Insights

Should it take over 17 years to become compliant?
What do you think is the root cause problem?
Suppose it has anything to do with top management and the culture within the Red Cross?

Surely problems this widespread can't be blamed on "operator error." It's not because some technician made too many mistakes. In our opinion it is inexcusable for an organization that's an American icon to have this miserable track record with complying with our nation's regulations for safe and pure products.

GMP Tip
One of our basic lessons when we teach GMP is that compliance costs less than non-compliance. Here's an example you can use in your GMP training to demonstrate this principle.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1344 clients since 1996

NEW for 2008!
Survival Kit for Regulatory Inspections
www.gmptrainingsystems.com/asp/survival_kit_FDA_inspections.asp

March 19-20 Anaheim, CA
GMPs for Dietary Supplements Boot Camp
www.gmptrainingsystems.com/asp/public_workshops.com

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Contaminated Syringes Recalled - Feb 4, 2008

2008-02-04T09:43:00.000-08:00

A nationwide recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes was issued by AM2PAT, INC. (doing business as Sierra Pre-Filled Inc). They have been found to be contaminated with Serratia marcescens, which has resulted in patient infections. The recall notice contains this sentence:

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Read the Recall Notice. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Tip
Keeping things clean and reducing the probability of contamination is a fundamental principle of GMP. Use this example in your GMP training sessions. Ask participants in your training to discuss the consequences of this recall. Then discuss how contamination can be prevented in your operation.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1337 clients since 1996

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Respond Effectively to FDA ... or else! - Jan 29, 2008

2008-01-30T09:10:00.000-08:00

Here's another Warning Letter issued by FDA for an inadequate response to a Form FDA 483, List of Inspectional Observations. This one was issued to Noven Pharmaceuticals, Inc. on Jan 4 - right after the holidays.

It is critical that we not only develop good, effective, science-based responses to an FDA inspection, but then implement what you said you would do. ESPECIALLY if you receive a Warning Letter - because you know the FDA will be back to reinspect after issuing a Warning Letter.

Read the letter issued to Noven. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1332 clients since 1996

Last call - GMP Boot Camp Feb 13-14
Fundamentals of GMP/QSR Anaheim, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

GMP for Dietary Supplements web seminar Feb 8
www.gmptrainingsystems.com/asp/GMP_store_080208.asp

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Systems Thinking discussion with Russ Ackoff - Jan 21, 2008

2008-01-21T20:08:00.000-08:00

David Markovitz, President of GMP Training Systems, Inc. here with some Breaking News!

Russ Ackoff, PhD is often referred to as the "Father of Systems Thinking." He's reached the age of 88 and still teaching and writing. I've had the privilege of spending a day with Dr. Ackoff in 2004 and I still refer to my notes from that day. With FDA's emphasis on a Systems-based Approach to their Inspections, there is a lot to learn from someone like Ackoff.

There is a discussion via teleconference with Dr. Ackoff on Jan 24 and 25 (2 hours each day) and you can participate at no charge. The InThinking Network is sponsoring this FREE seminar with Dr. Ackoff. This is possible through an arrangement they have with Pratt and Whitney/Rocketdyne and the Boeing Corp. (It helps to have a rich patron.)

For details, go to:
w ww.gmptrainingsystems.com/asp/Ackoff.asp

We've posted four articles by Dr. Ackoff for you to download with our compliments. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1331 clients since 1996

GMP Boot Camps 2008
Fundamentals of GMP for FDA Regulated Industries
Feb 13 - 14 Anaheim/Newport Beach, CA
GMP for Dietary Supplements New for 2008
Mar 19-20 Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/Public_workshops.asp

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Effective Response to FDA 483 is Critical - Jan 14, 2008

2008-01-14T08:02:00.000-08:00

After an FDA inspection resulting in the issuance of a Form FDA 483, List of Inspectional Observations, it is CRITICAL to respond to the FDA EFFECTIVELY. If you don’t, it could and often does lead to serious consequences.

Recently a company received a Warning Letter (just before Christmas) because of their inadequate response.

To read this Warning Letter issued to G. Dundas Company, Inc., go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

One issue they were cited for: “You could not provide written training procedures during the inspection and a training record for an employee who has been employed for six months.”

GMP Tip

Lack of written training procedures and training documentation can lead to a Warning Letter. This is so easy to do that it should never be cause for a Warning Letter. But it takes resources and commitment to get it done.

Does your company have the resources necessary for compliance?

Does your company have the commitment to make cGMP compliance a priority?

Does your company invest the time to prepare an effective response to a 483, and then follow through with implementation?

If you answered no to any of these questions, you might want to share this Warning Letter with your management team.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1329 clients since 1996

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Innovate in 2008 - Jan 8, 2008

2008-01-08T13:29:00.000-08:00

Leading edge organizations practice innovation as a way of life. This is particularly challenging in heavily regulated industries. Learning how to make innovation happen in this environment requires understanding innovation in more than one context.

Here's another short e-book entitled "The Six Core Values of Innovation" that addresses this issue succinctly. It's our New Year's gift to you so you can get a great start in 2008.

Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1323 clients since 1996

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Innovation: More Than a New Year's Resolution - Jan 2, 2008

2008-01-02T08:55:00.000-08:00

Happy New Year!

"Innovation is defying complacency by continually seeking and seizing improvements, one scenario at a time." from Innovation: More Than a New Year's Resolution.

Get a great start in 2008 by reading this terrific little e-book on Innovation. Download it now as our New Year's gift to you. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1319 clients since 1996

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Food Safety Tips for Healthy Holidays - Dec 18, 2007

2007-12-18T08:26:00.000-08:00

FDA just published an article entitled Food Safety Tips for Healthy Holidays. You can find it at:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

The entire staff of GMP Training Systems, Inc. wishes you and your family the happiest and healthiest holiday season.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1307 clients since 1996

GMP Boot Camps 2008
GMP for Dietary Supplements Jan 23 - 24 Anaheim, CA
Fundamentals of GMP for FDA Regulated Industries
Feb 13 - 14 Virginia Beach, VA
www.gmptrainingsystems.com/asp/Public_workshops.asp

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More Bad News for the FDA - From the FDA Itself - Dec 3, 2007

2007-12-03T18:59:00.000-08:00

"FDA's inability to keep up with scientific advances means that American lives are at risk," says a report issued on Dec 3.

This report, entitled "FDA Science and Mission at Risk," was commissioned by FDA's Commissioner in order to assess whether its scientific expertise can support its regulatory mission.

Read this 56-page report. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1297 clients since 1996

JUST RELEASED! NEW INNOVATIVE PRODUCT!
Our Web-based On-line GMP Training System, twelve modules, is up and ready to go. Perfect for new and temporary employees.
www.gmptrainingsystems.com/asp/Web_based_training.asp

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Dirty Tank Causes Contaminated Products Nov 27, 2007

2007-11-26T14:10:00.000-08:00

The European Medicines Agency (EMEA) carried out an inspection of Roche's active ingredient manufacturing facility in Basel in collaboration with Swiss regulators Swissmedic, to assess conditions at the plant where the contamination of Viracept occurred.

They discovered a holding tank, used to store the starting material for the last step of the drug's manufacturing process, was not part of Roche's cleaning Standard Operating Procedure (SOP). The tank, in fact, was not cleaned at all between 2001 and the end of the company's April 2006 production run.

Perhaps one of the most unnerving aspects was that one of the root causes of contamination during Viracept's history was the "lack of knowledge and understanding with regard to the manufacturing process" exhibited by the drug's manufacturer.

"This may be due to the fact that the production process was originally purchased from another company," the assessment report suggests.

Read the entire news account. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Key Insight
With mergers and acquisitions within the FDA regulated industries comes the danger of losing key "institutional knowledge." This is also critical in companies in a "downsizing" mode and/or where early retirements are encouraged as a means to cut costs.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1299 clients since 1996

JUST RELEASED! NEW INNOVATIVE PRODUCT!
Our Web-based On-line GMP Training System, twelve modules, is up and ready to go. Perfect for new and temporary employees.
www.gmptrainingsystems.com/asp/Web_based_training.asp

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China Gets Serious on Drug GMP - Nov 19, 2007

2007-11-19T14:06:00.000-08:00

Effective January 1, 2008, China's State FDA will no longer tolerate the detection of any "severe defects" during a GMP accreditation process, meaning that such a finding will result in automatic failure.

China has only been requiring pharmaceutical manufacturers to comply with GMP since 2004, and has granted accreditation if less than three "severe defects" are discovered. An example of a "severe defect" is the falsification of application documents.

The US FDA and China's SFDA have been working together for the past six months on a safety pact between the two countries. Looks like there's some real progress being made here.

Read the entire news account. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

To our US based readers, have a Happy Thanksgiving holiday.
Read FDA's article - Home for the Holidays: Preventing Foodborne Illness at Family Gatherings
Find it at http://www.cfsan.fda.gov/~dms/fdholida.html

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1293 clients since 1996

The FDA Just Can't Win - Nov 13, 2007

2007-11-13T14:09:00.000-08:00

The FDA is damned if it does, and damned if it doesn't. A recent article in Fortune states that after years of public ridicule and congressional scrutiny, the FDA is taking a tougher stance against drugmakers in its review of new medicines. That new cautiousness, however, rankles its most powerful constituents: Big Pharma CEOs who charge that the agency is standing in the way of new medicines - and progress.

So is the FDA really to blame?

An interesting assessment of FDA's relationship with our industry.

Read the entire article. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1288 clients since 1996

Keeping Current with GMPs - Oct 30, 2007

2007-10-30T09:01:00.000-07:00

We all know that the "c" in cGMP stands for current. A recent Warning Letter has proven helpful in better understanding the importance of keeping current. This Warning Letter was issued to a compounding pharmacy - which often manufactures drug products in an environment that is not cGMP compliant.

Reading FDA's commentary in this Warning Letter and the associated observations (24 majors) makes for an an interesting case study in why it's critical to stay current.

To read the letter, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1278 clients since 1996

GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

JUST RELEASED! NEW!
Our on-line GMP Training System, twelve modules, is up and ready to go. Perfect for new and temporary employees.
www.gmptrainingsystems.com/asp/Web_based_training.asp

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Law and Order Takes on the FDA - Oct 22, 2007

2007-10-22T08:08:00.000-07:00

David Markovitz here with another personal story.

Last week I was watching my favorite TV show, Law and Order: Criminal Intent. It’s the one with quirky Detective Goren, a modern day Columbo. The plot revolved around a counterfeit mouthwash contaminated with DEG (diethylene glycol). An FDA Field Investigator discovers the contaminated mouthwash after children die and writes a memo to his superiors recommending an immediate recall. The FDA Regional Director shreds his copy to protect his college buddy, now the head of the pharmaceutical company targeted by the counterfeiters. The Deputy Director has her eye on the Director’s job, murders the Field Investigator using a counterfeit asthma inhaler (with no active ingredient) and tries to frame her boss in order to get his job. Of course, the detectives figure it out and arrest the Deputy Director of the FDA.

Now the Real World FDA
The FDA has been pummeled by the media and members of Congress in the past three years for a series of contaminated products, product withdrawals, recalls, a convicted Commissioner, the plan to close and consolidate labs, and other issues. Now a popular television show portrays the FDA in the worst possible light.

What Can We Expect from the FDA?
Expect FDA inspections to continue to be tough and get even tougher as they fight this image of incompetence, ineptness, and not caring for the consumer. In the TV show, the only FDA rep who cared for the consumer ended up dead.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1273 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

JUST RELEASED!
Our on-line GMP Training System, twelve modules, is up and ready to go. Perfect for new and temporary employees.
www.gmptrainingsystems.com/asp/Web_based_training.asp

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Tylenol's "I Promise" campaign wins our praise - Oct 16, 2007

2007-10-16T18:44:00.000-07:00

David Markovitz, President of GMP Training Systems, Inc. here to tell you a personal story.

"Last week while watching television I saw a remarkable ad for a drug product we're all familiar with - Tylenol. What was remarkable was that it featured employees who make Tylenol telling us about the care that they personally put into their jobs and their promise to do everything not to betray our trust. WOW! Quite different from the "Go tell your doctor you need ....." advertising that has become so prolific on our TV screens lately."

See for yourself - go to:
http://www.tylenol.com/promise

Training Tip
Maybe you can't launch a national advertising campaign from your office, but surely there's some element of this approach you can emulate in your company. How about an ad campaign within your company reminding people how important each job is, how each person in their own way contributes to a product that customers trust in?

Congratulations to McNeil Consumer Healthcare for this refreshing approach to marketing their product - touting their GMP compliance in terms their customers can understand and embrace.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1270 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Timely programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Contamination Leads to Company Demise - Oct 7, 2007

2007-10-07T09:49:00.000-07:00

A 67 year-old company that manufactured hamburgers for its own brand and some of the largest private label brands on the market has been forced to recall so much meat that it is going out of business.

Topps Meat Company LLC announced that because of the economic impact of the second-largest beef recall in U.S. history involving more than 21.7 million pounds of ground beef products, it is forced to close its Elizabeth plant and go out of business immediately. The company has been in business since 1940.

The tons of frozen ground beef products were recalled because they may be contaminated with E. coli.

"This is tragic for all concerned," said Anthony D’Urso, Topps chief operating officer. "In one week we have gone from the largest U.S. manufacturer of frozen hamburgers to a company that cannot overcome the economic reality of a recall this large. We sincerely regret the impact this will have on our employees, our customers and suppliers, and the community.”

Read the entire news report. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip

A sad example of how contamination can harm customers, destroy a company, throw people out of work, and impact a community. Use this example in your GMP training to emphasize the need to keep things clean.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1267 clients since 1996

Personal Productivity - Oct 1, 2007

2007-10-01T08:50:00.000-07:00

Have you ever been frustrated in getting your ideas for improvement accepted?

Learning how to "sell" your ideas effectively can help you propel your career forward.

We've recently found a terrific short e-book which offers great tips on how to do this well. Find it in our new section on Personal Productivity on our Resource page. It's free!
www.gmptrainingsystems.com/asp/resources.asp
Click on Personal Productivity.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1264 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Twelve terrific programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Drug or Sanitizer? A Fine Line is Drawn by FDA - Sept 24, 2007

2007-09-24T08:12:00.000-07:00

Proctor & Gamble received a Warning Letter from FDA recently because of the way they labeled and were promoting a new foaming hand sanitizer. FDA dug into the details, including what P&G was saying on their web site about the product, and determined that the product as defined by P&G is a drug.

This Warning Letter is an interesting case study of the depth the FDA goes into in their investigations. Read the Warning Letter and forward it to your Marketing group. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1259 clients since 1996

Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Eleven terrific programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Mayo Clinic Conference - Sept 17, 2007

2007-09-17T16:56:00.001-07:00

The Founder and President of GMP Training Systems, Inc., David Markovitz, will be sharing the platform with FDA Commissioner Andrew von Eschenbach, MD at the Mayo Clinic Clinical Research Conference in Minneapolis, MN this week. von Eschenbach's talk is on "Individualized Medicine." Markovitz' talk is titled "How to Optimize a System to Maximize Productivity in Clinical Research."

Learn more about this conference here:
www.mayocts.com/research/agenda.html

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1253 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Fourteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Dietary Supplement or Drug: FDA decides - September 4, 2007

2007-09-04T14:28:00.000-07:00

Sometimes the difference between a Drug and a Dietary Supplement is in the dosage. Read this excerpt from a recent Warning Letter.

You promote Cholestrix as a dietary supplement. Your website states, "Sunburst's Cholestrix is made from a specially concentrated red yeast rice extract which is standardized to contain 1.35% of naturally occurring lovastatin. Just 2 capsules per day provide 10mg. of natural lovastatin." Lovastatin is the active pharmaceutical ingredient in Mevacor and its generic counterparts, which are FDA-approved drugs to treat patients with primary hypercholesterolemia.

Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because Cholestrix contains red yeast rice with enhanced or added lovastatin, and bears a claim about the "powerful cholesterol fighting" benefits supplied by this ingredient, it cannot be marketed as a dietary supplement.

Read the entire Warning Letter and a similar Warning Letter issued by FDA last month to Swanson Health Products Inc. and Sunburst Biorganics. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1248 clients since 1996

An Eye-Popping Warning Letter - August 27, 2007

2007-08-27T14:16:00.000-07:00

Sometimes you read a Warning Letter that makes your eyes pop out. Here are excerpts from one such letter recently issued to a manufacturer of contact lenses.

The change control procedure, among others, remains unsigned and undated. Changes were observed having been made via the addition of "post-it" notes.
No record accompanies each pair of lenses nor is a record created concurrent with each step of production.
No audits have been performed since your firm began manufacturing in 2000.
No acceptance procedures for finished devices have been established and device history records do not include documentation of a final review to assure lenses are manufactured in accordance with device master records.

Read the entire Warning Letter. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down. Look for
Crystal Reflections International Warning Letter June 14, 2007

Training Tip
Use Warning Letters in your GMP training sessions as a way to learn from other peoples’ experience (OPE).

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1243 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Fourteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Parent's Guide to Kids' Vaccines - August 22, 2007

2007-08-22T13:47:00.000-07:00

Many of us are preparing for Back-to-School at this time of the year. FDA just published an article entitled "A Parent's Guide to Kids' Vaccines." This is a very comprehensive guide that every parent should have. If you're a grandparent, print this and give it to your children. Planning a family? Print this and save it for future reference.

Find this article at:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1239 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Thirteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Schering-Plough Climbs Back - August 13, 2007

2007-08-13T08:02:00.000-07:00

Schering-Plough announced earlier this month that a consent decree filed against the company in May 2002 had been dissolved by the US District Court. This is the court action that was issued for violations of GMP and resulted in a fine of $500 million.

What other extraordinary costs were experienced in this climb back from the abyss.

What about the costs to peoples’ careers?
What about the cost to peoples’ health? (Stress levels when operating under a court order are unusually high.)
What about the cost to the company’s reputation and ability to recruit top talent?

Few companies today have the size, resources, strength, and momentum that Schering-Plough has to come back. Many companies in this situation shrink to a smaller operation, become targets for takeover, or simply go out of business.

See what Schering-Plough’s people had to do to get back into compliance. Read the 46-page Consent Decree issued to Schering-Plough in May 2002. Go to:

www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip
This entire episode could have been prevented had people in the organization been focused on GMP and making it a Lifestyle in the company. PREVENTION ALWAYS COSTS LESS THAN CORRECTION. Make sure your management team is aware of this Consent Decree and the five years it took to get back into compliance.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1235 clients since 1996

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Thirteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

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Planning GMP Training in 2007 - August 8, 2007

2007-08-08T13:53:00.000-07:00

Are you planning GMP training this fall?

Now is the time to start planning for programs in September – December. The logistics for training can be a challenge, especially when planning plant-wide training.

Training Tips
1. Work with your Manufacturing and Planning departments now to identify the optimum times for scheduling the training.

2. Contact GMP training suppliers now for dates in 2007. Our calendar gets quite crowded during the months of October – December.

GMP Training Systems, Inc. was founded in 1996 by David Markovitz, after gaining two decades experience in Operations Management in the industry. Learn more about our faculty at:
www.gmptrainingsystems.com/asp/about_us.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1231 clients since 1996

See our entire Web Seminar schedule:
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Our Two-year Anniversary: THANK YOU - August 1, 2007

2007-08-01T12:43:00.000-07:00

We started the GMP Training and Implementation Tips web portal two years ago. We express a hearty "Thank you" to our faithful readers.

This is the 102 posting - this means that there are 101 useful tips archived right here for you to use. If you are a relatively new subscriber, spend some time going through our archived postings. You'll find a treasure trove of examples to liven up your GMP training.

You can also find numerous helpful documents in our Resource section of our web site.
www.gmptrainingsystems.com/asp/resources.asp

As we start our third year, we invite you, our readers, to send in your tip. We'll publish it here and give you the credit. Send your GMP Tips to info@gmptrainingsystems.com.
Put GMP Tips in the subject line so we are sure to find it.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1225 clients since 1996

Coming soon: A comprehensive on-line GMP course consisting of twelve modules. Excellent for new employees, temporaries and contactors. We strive to make your job easier.

Our next popular GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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FDA says GMP Compliance Going from Bad to Worse - July 30, 2007

2007-07-30T08:38:00.001-07:00

At a recent industry meeting, David Horowitz, FDA Office of Regulatory Affairs deputy associate commissioner for compliance policy, noted industry compliance with GMPs "is bad and getting worse." He remarked that manufacturers are "studying for the test"—correcting specific deficiencies but not investing in systems that can avoid problems and correct root causes.

FDA is urging manufacturers to adopt innovative approaches for ensuring that drugs meet quality standards, as seen in its Quality Systems Approach to Pharmaceutical CGMP Regulations guidance published in September 2006.

The new Q10 standard from the International Conference on Harmonization further describes approaches for harmonizing quality systems on a global basis.

How is GMP compliance in your company?
Bad and getting worse?
OR
Good and getting better?

Find both FDA’s guidance and the Q10 document at:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1223 clients since 1996

Upcoming web seminars
Aug 2 Commissioning and Validation of Critical Utilities series
Aug 10 How to Manage Regulatory Inspections series
Aug 23 Sample Preparation for HPLC
Aug 30 Common Problems with Gradient Elution Liquid Chromatography: Proven Solutions and Prevention Strategies
Sept 20 The Effective Use of Statistics in Design Method Validation series

See our entire Web Seminar schedule:
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
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Contamination! AIDS Drug Recalled - July 23, 2007

2007-07-23T13:20:00.000-07:00

Roche Pharmaceuticals last month announced a global recall of its HIV/AIDS drug Viracept after discovering that some batches had been contaminated with a carcinogen during a flawed manufacturing process at its Swiss plant.

Tens of thousands of people take Viracept worldwide, most of them poor people with the acquired immune deficiency syndrome in developing countries.

A spokeswoman for Roche said the contaminant, ethyl mesilate, should be called an "impurity" rather than a contaminant because it was created in the manufacturing process and because this type of chemical can be found in very low levels in other medicines, although it was not supposed to be present in Viracept.

At high doses, ethyl mesilate has been shown to cause cancer in animals, and at lower levels it has caused genetic mutations, but data are extremely limited.

It is particularly harmful to children and pregnant women.

Impurity or contaminant – it’s a GMP problem!

Training Tip
In your GMP training sessions, discuss the impact of issues like this on poor people in developing countries. They have enough challenges in life, and this just compounds their struggle to exist.

Read the entire article published in the New York Times on July 23. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1217 clients since 1996

Upcoming web seminars
July 27 Sample Preparation for HPLC
Aug 2 Commissioning and Validation of Critical Utilities series
Aug 10 How to Manage Regulatory Inspections series
Sept 20 The Effective Use of Statistics in Design Method Validation series

See our entire web seminar schedule:
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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ICH Q10 Ready for Comment - July 19, 2007

2007-07-19T15:35:00.000-07:00

The FDA recently announced the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal Register. The public comment period is open until October 11, 2007.

The ICH Q10 draft guideline describes one approach for “an effective pharmaceutical quality system that is based on ISO concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 ‘Pharmaceutical Development’ and Q9 ‘Quality Risk Mangement.’” The guideline, which is optional, applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.

Read the Q10 Guidance document. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1214 clients since 1996

See our web seminar schedule
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach,CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Chinese FDA Chief Executed!!! July 12, 2007

2007-07-12T20:02:00.000-07:00

BEIJING, July 10 (Bernama) -- The Supreme People's Court executed former director of China's State Food and Drug Administration (SFDA) Zheng Xiaoyu on Tuesday morning, after finding him guilty of taking bribes amounting to US$850,000 (6.49 million yuan) and dereliction of duty.

Read a full article detailing this startling action. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Correction: Cao Wenzhuang, who we reported on earlier this week, was former head of the drug registration department of the SFDA, not Chief.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1199 customers since 1996

Chinese FDA Chief gets Death Penalty - July 9

2007-07-09T10:10:00.000-07:00

BEIJING, July 7 (UPI) -- A former top official with the state Food and Drug Administration in China has been sentenced to death for taking bribes to approve defective drugs.

Cao Wenzhuang was given a two-year reprieve Friday on the execution of his sentence, The New York Times reported. That means there is a good chance the sentence will be commuted to life imprisonment, the newspaper said.

In February 2007, former FDA Commissioner Lester Crawford was sentenced to three years' supervised probation with fines of roughly $90,000 for lying about stocks he owned in companies regulated by the FDA while he was Commissioner. Crawford pled guilty in October 06 to charges of having a conflict of interest and false reporting of his stock records.

Crawford should be thankful he headed the US FDA and not China’s FDA.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1197 clients since 1996

Last call for our GMP Boot Camp July 18 - 19
Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
Only three seats left!

Understanding cGMPs for Dietary Supplements
Web seminar July 13 For more information and to register, go to: www.gmptrainingsystems.com/asp/gmp_store_070713.asp

Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.asp

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Medical Device Consent Decree - July 2, 2007

2007-07-02T12:38:00.000-07:00

Shelhigh, Inc., of Union, N.J., agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.

Shelhigh manufactures pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts.

Pediatric heart valves. Every parents' nightmare is to be told that your baby needs heart surgery and possibly an artificial valve to replace the defective valve they were born with. What would you do if your baby had a valve replacement three months ago and today you discover it was a Shelhigh valve?

On April 17, 2007, U.S. Marshals seized all finished devices and components of the devices at Shelhigh's manufacturing facility due to concerns of potential risk of nonsterility.

The consent order requires that the company hire independent expert consultants to inspect its facility and certify to FDA that corrections have been made. (How much do you think this will cost vs. the cost to prevent this from occuring in the first place?)

Read FDA's Press Release announcing this Consent Decree.
Go to: www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip
During your GMP training sessions, discuss how nonsterile products could occur in your facility. Discuss the importance of following procedures. Discuss the consequences and cost that Shelhigh now faces and the potential impact on its employees.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1189 clients since 1996

Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
Only three seats left!

NEW! NEW! NEW!
GMP for Dietary Supplements Boot Camp
August 1 and 2 Anaheim/Newport Beach, California.
For more information and to register, go to:
www.gmptrainingsystems.com/asp/public_workshops.asp

Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.asp

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GMP for Dietary Supplements - They're Here! June 25, 2007

2007-06-25T09:01:00.000-07:00

On Friday, June 22, FDA released the long awaited cGMP for Dietary Supplements.

Read FDA's Final Rule and the GMP regulation.
Read FDA's Press Release and their Backgrounder document.
Read FDA's Consumer article on the Safe Use of Dietary Supplements.

Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on cGMP for Dietary Supplements.

GMP Training Systems is announcing the FIRST workshop and web seminar to examine this new regulation.

Web seminar July 13 from 11:00 am to Noon EDT. For info and to register, go to:
www.gmptrainingsystems.com/asp/gmp_store_070713.asp

Workshop August 1 and 2 in Anaheim/Newport Beach, California. For more information and to register, go to:
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1183 clients since 1996

NEW! NEW! NEW!
Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.asp

Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
Almost full - call now to reserve your seat.

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FDA Under Pressure to Inspect Foreign Firms - June 21, 2007

2007-06-21T11:57:00.000-07:00

An article in the Washington Post states that generic drugs are increasingly being manufactured by companies based in India and China. Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made in the USA, come from India and China.

The article states that experts say medicines from China and India pose a risk of being contaminated, counterfeit or simply understrength and ineffective.

William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating. "You have this confluence of events, with so much more product coming from abroad and fewer and fewer inspections," Hubbard said. "This is very serious stuff, because a contaminated drug hitting the market could cause lots of injuries or worse before it got tracked down." He also said that the FDA inspection system is so weak that many foreign manufacturers believe they "can play games without consequences."

Read this entire article. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1177 clients since 1996

NEW! NEW! NEW!
Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.asp

Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
Just a few seats left in this workshop.

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FDA Takes More Heat from Congress - June 12, 2007

2007-06-12T16:12:00.000-07:00

This week USA Today had the following headline – FDA called “cozy” with Drugmakers. The story reads that while revising their drug-review policy last year, FDA officials met 112 times with industry representatives but only five times with consumer and patient groups, according to data out Monday from the House Appropriations Committee.

"The FDA has essentially become the government affairs office of the pharmaceutical industry," Rep. Maurice Hinchey, D – N.Y. said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."

Our Analysis and Speculation
FDA may conduct harsher inspections to prove that they are “less cozy than perceived.” Be prepared for tougher inspections.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1167 clients since 1996

NEW! NEW! NEW!
Fundamentals of HPLC workshop LIVE on-the-web
July 13, 20, and 27
This is the same course LC Resources conducts in-person. Now using distance learning technology, we bring this course into your facility LIVE.
www.gmptrainingsystems.com/asp/lc_store_070713.asp

Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
Who in your group needs to come up to speed quickly?

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Shades of 1937 and AMO's Response - June 4, 2007

2007-06-04T09:48:00.000-07:00

On June 1, FDA issued an Import Alert to prevent toothpaste containing the poisonous chemical diethylene glycol from entering the United States.

Diethylene glycol is the same ingredient that led to deaths of over 100 people in 1937 during the infamous elixir of sulfanilamide incident. This tragedy led directly to the passage of the Federal Food, Drug, and Cosmetic Act in 1938.

Read FDA's Press Release as well as an FDA article, "Taste of Raspberries, Taste of Death," detailing the 1937 incident. Go to www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Here's a quick follow-up to last week's recall by Advanced Medical Optics.

The company said it "Stands by its product and blamed improper handling of contact lenses for the eye infections that forced the product to be pulled from the shelves."

Do you think it's a smart strategy to blame your customers?

Would it not have been a better strategy to say something like, "Together with the Centers for Disease Control and Prevention, we are continuing to investigate the cause of the eye infections that seem to be associated with one of our products. Because we value the health and welfare of our customers, we have voluntarily recalled the product. We will continue to search for the possible causes and immediately rectify any issues should they prove to be associated with our manufacturing or distribution processes."

Stay tuned to see how this develops.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1161 clients since 1996

Our next GMP Boot Camp is July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp
There are still a few seats left.

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Another Contact Lens Solution Recalled - May 29, 2007

2007-05-29T10:48:00.000-07:00

Advanced Medical Optics (AMO) announced a recall of one of their contact lens solutions on May 25 because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). This could be a direct GMP issue - contamination during the manufacturing process.

Last November AMO recalled 18 batches of contact lens solutions for contamination problems. Just last week AMO said they would try to acquire Bausch and Lomb, who announced last week that they were being acquired by a private equity investment firm.

Read FDA's announcement of AMO's voluntary recall. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Perhaps the management at AMO should be focusing more energy on producing high quality products and less on acquiring competitors.

Is it just us, or is there a considerable increase in contamination issues lately?

It's a good idea to conduct an internal audit at your firm and focus on cleaning and reducing the risk of contamination.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1153 clients since 1996

Our GMP Boot Camp is filling up fast.
July 18 - 19 Virginia Beach,VA
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How a GMP Issue Can Take Down a Company - May 21, 2007

2007-05-21T09:33:00.000-07:00

You may remember last May (2006) when Bausch and Lomb recalled one of its contact lens cleaning solutions (a $100 million-a-year product) because of an outbreak of potentially blinding infections. At first they denied that there was a problem with the product, but enough evidence surfaced to warrant the recall.

It is no surprise that B&L’s sales for 2006 fell significantly. In their struggle to recover, they have agreed to a buyout by a private equity investment firm. B&L was started in 1853 by John Jacob Bausch, a German immigrant, who set up an optical goods shop in Rochester, NY. He borrowed $60 from his partner Henry Lomb.

It’s a sad tale that after 154 years; a company is taken down by a contaminated product. Clearly this was a GMP issue, and could have been prevented.

Some background on this case.
We reported in April 2006 that the fungus infection problem surfaced and B&L’s CEO at that time said that their product was "as safe and effective as anything on the market." Four weeks later, one day after receiving an eleven page 483 from FDA, B&L issued the recall. Five months later, In October 2006, B&L received an eleven page Warning Letter from FDA. Now they’re being bought out. This is a classic example of what we call “the death spiral.”

We generally find the death spiral syndrome where GMP and Quality are not part of a company’s culture. Some companies “Get it” and some companies “Don’t get it.”

Sadly, for the customers and employees of B&L, their current management “Didn’t get it.”

Read the 483 and Warning Letter issued to B&L in 2006. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1147 clients since 1996

Upcoming educational programs:
Web seminars
Digging for the Truth in Gas Chromatography series
May 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Our GMP Boot Camp is filling up fast.
July 18 - 19 Virginia Beach,VA
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First Peter Pan, Now Hostess - May 15, 2007

2007-05-15T13:40:00.000-07:00

American icons are falling like dominos. A few weeks ago, Peter Pan Peanut Butter was recalled for salmonella contamination. Now Hostess is recalling one of their products.

FDA announced on May 14 the voluntary recall of 3.25-ounce snack packages of Hostess Mini Pound Cakes. FDA said that Interstate Brands Corp. recalled the packages due to a packaging error. Officials said some of the packages might contain Hostess Carrot Cake, which is made with walnuts, posing a potential life-threatening problem for people who have an allergy or severe sensitivity to walnuts.

Training Tip
This mix-up is HUGE - putting the product in the packaging for a different product. Use this example in your GMP training sessions to emphasize the need to conduct a thorough line clearance procedure in between different products. Discuss the potential cost to the company if this were a pharmaceutical or medical device product.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1139 clients since 1996

Upcoming educational programs:
Web seminars
HPLC Troubleshooting & Preventive Maintenance series
May 18 and 24
Digging for the Truth in Gas Chromatography series
May 16, 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp June 6 – 7 Anaheim, CA
GMP Boot Camp July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp

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More Controversy at FDA - May 10

2007-05-10T15:20:00.000-07:00

A Food and Drug Administration plan to close seven of 13 field laboratories has angered some lawmakers, government workers and safety advocates, who fear the move will chase away skilled veteran employees and hurt the FDA's ability to respond to public health emergencies.

Several of the facilities helped investigate the recent pet food scare and E. coli and salmonella outbreaks in spinach and peanut butter. On the heels of these crises, the proposed lab closings have been met with strong suspicion.

"In the middle of all these outbreaks and contamination issues, the timing of the proposal is extraordinarily bad," said Chris Waldrop, director of the Food Policy Institute at the Consumer Federation of America.

Read this story from McClatchy News. Go to:
www.gmptrainingsystems.com/asp/rersources.asp
Click on Timely Resource Articles and scroll down.

Our take on this issue
Over the years we've learned that timing is critical when striving for acceptance of a plan that represents change. This may be a good plan, but the timing is bad, given all the criticism FDA has been taking recently.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1131 clients since 1996

Upcoming educational programs:
Web seminars
HPLC Troubleshooting & Preventive Maintenance series
May 11, 18, 24
Digging for the Truth in Gas Chromatography series
May 16, 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp June 6 – 7 Anaheim, CA
GMP Boot Camp July 18 - 19 Virginia Beach,VA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Senate Looks to Give FDA More Power, More Money - May 1, 2007

2007-05-01T13:49:00.000-07:00

The Senate began debate on Monday on a bill that could fundamentally change the way the FDA operates by giving it more power and money to ensure that drugs are as safe as advertised. The measure, which has bipartisan support, would renew and increase the fees paid by regulated drug companies.

“This is the most important legislation for FDA in at least 10 years and, probably, forever on issues of drug safety,” said Dr. Mark B. McClellan, a former food and drug commissioner.

Dr. David A. Kessler, another former commissioner, said, “This is a pivotal moment in FDA’s history, as important as 1938 or 1962, when Congress gave the agency its fundamental responsibilities.”

“The FDA should be the gold standard for safety, but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs,” Sen. Edward Kennedy said on the Senate floor.

Read this article from The New York Times. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1125 clients since 1996

Upcoming educational programs:
Web seminars
HPLC Troubleshooting & Preventive Maintenance series
May 4, 11, 18, 24
Digging for the Truth in Gas Chromatography series
May 16, 30 and June 21, 28
Environmental Monitoring: The True Reasons
May 23
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp June 6 – 7 Anaheim, CA
GMP Boot Camp July 18 - 19 Virginia Beach, VA
www.gmptrainingsystems.com/asp/public_workshops.asp

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FDA Under Fire - AGAIN! Apr 24, 2007

2007-04-24T14:56:00.000-07:00

FDA is once again being criticized for its actions (or shall we say inactions) with the recent spate of recalls. The Washington Post reported that FDA was aware of contamination problems at a Georgia peanut butter plant years before a salmonella outbreak. An FDA report shows that FDA inspectors checked into complaints about contamination in a ConAgra Foods plant in Georgia in 2005. This plant has now been closed.

Congress has scheduled hearings this week on the issue of contamination in our food supply. Stay tuned.

PREDICTION
Expect the FDA to adopt a Get Tough policy in their inspections.

Read the Washington Post story. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1117 clients since 1996

Upcoming programs:
Troubleshooting HPLC Pumps and Autosamplers
Audio seminar Apr 27
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp Jun 6 – 7 Anaheim, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Another recall - CONTAMINATION AGAIN! - April 16, 2007

2007-04-16T16:03:00.000-07:00

Last week FDA announced a voluntary nationwide recall of all lots of Listerine Agent Cool Blue Plaque-Detecting Rinse.

The FDA said the manufacturer of the rinse, McNeil-PPC Inc., a Johnson & Johnson subsidiary, decided to recall approximately 4 million bottles after finding the rinse had been contaminated with microorganisms.

Training Tip
In your GMP training session, have small groups discuss ways in how this contamination may have occurred. Then ask them to provide measures which could be implemented to prevent such contamination. You can also ask them to discuss all the costs associated with this recall and its impact on the company.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1103 clients since 1996

Upcoming audio seminars:
Principles of HPLC Troubleshooting April 20
A Case Study in Commissioning and Validation Apr 25
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp Jun 6 – 7 Anaheim, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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When Will They Ever Learn? - Apr 10, 2007

2007-04-10T09:00:00.000-07:00

On March 13, Abbott Laboratories, Inc. received another Warning Letter from FDA, this time for their Diagnostics Division operation in Dallas. This follows a Consent Decree that the Abbott Diagnostics Division received from FDA in 1999 for the Abbott Park operation in Illinois.

Some of you may remember the 1960’s folk song, Where Have All the Flowers Gone?, and the chorus from that song, that goes “When Will They Ever Learn?”

Dealing with Warning Letters and Consent Decrees adds a tremendous cost burden on any company. It also adds a tremendous stress burden on the employees.

These FDA actions are best avoided simply by:

Keeping current on cGMP regulations.
Following cGMP regulations.

Training Tip
Use these two documents in your GMP training to emphasize the benefit of compliance and the perils of non-compliance. Lead a discussion on all the consequences and ramifications companies face when issued documents like these from FDA.

Read Abbott’s latest Warning Letter and the 1999 Consent Decree. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

See Mary Travers and the Kingston Trio perform Where Have All the Flowers Gone?
http://www.youtube.com/watch?v=vg8Db7VNgL0

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1097 clients since 1996

Upcoming programs:
A Case Study in Commissioning and Validation
Audio seminar Apr 25
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Statistics Boot Camp May 23 – 24 Washington, DC.
Quality Systems Boot Camp Jun 6 – 7 Anaheim, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

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Quality Systems - Are you making progress? - Apr 2, 2007

2007-04-02T14:07:00.000-07:00

Last week, David Markovitz, President of GMP Training Systems, Inc. lectured on Implementing FDA’s Quality System Guidance at a conference on Quality Systems sponsored by Advanstar Communications and the Institute of Validation Technology.

Last October David conducted this same program as an audio seminar. The audio recording of this seminar as well as the handout is available for purchase. Go to:
www.gmptrainingsystems.com/asp/lcgc_archives.asp
Click on Archived audio seminars.

We have also posted an FDA presentation on Implementing Quality Systems on our Resource section. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down to find this presentation by Chris Joneckis, PhD FDA CBER from August 2006.

Announcing a NEW workshop on Implementing FDA’s Quality Systems Approach to Pharmaceutical cGMP Regulations - June 6 – 7 in Anaheim, California.
To register, go to:
www.gmptrainingsystems.com/asp/public_workshops.asp

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1084 clients since 1996

Last call for our GMP Boot Camp on April 18 - 19
in Anaheim, CA. Learn more at:
www.gmptrainingsystems.com/asp/public_workshops.asp

Our next Statistics Boot Camp is May 23 - 24
in Washington, DC.Introduction to Statistical Methods for FDA Regulated Industries. Learn more at:
www.gmptrainingsystems.com/asp/public_workshops.asp

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2007 or 1907? - March 20, 2007

2007-03-20T13:04:00.000-07:00

Last fall it was contaminated spinach.
Last month it was contaminated peanut butter.
This week it's contaminated pet food.

Sounds more like 1907, not 2007.

Actually it was 1906 when the Pure Food and Drugs Act was enacted. This followed an outcry of contaminated foods and drug products.

We have three interesting articles about this era available.

Go to:
www.gmptrainingsytstems.com/asp/resources.asp
Click on FDA Resources. Scroll down to:
Centennial of the 1906 Pure Food and Drugs Act
Then scroll down to Timely Resources Articles and find:
Centennial of The Jungle
How Theodore Roosevelt Made Your Dinner Safe to Eat

With all this attention on contamination, look for Congress to put pressure on FDA to ENFORCE, ENFORCE, ENFORCE. Be prepared. This is the time to conduct internal audits and take action to make any corrections.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1077 clients since 1996

Our GMP Boot Camp on April 18 - 19
in Anaheim, CA is filling up fast. Learn more at:
www.gmptrainingsystems.com/asp/public_workshops.asp

Our next Statistics Boot Camp is May 23 - 24
in Washington, DC.
Introduction to Statistical Methods for FDA Regulated Industries. Learn more at:
www.gmptrainingsystems.com/asp/public_workshops.asp

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Big Batch of Warning Letters - March 13, 2007

2007-03-13T12:49:00.000-07:00

The FDA issued thirty eight Warning Letters in February 2007. Eight of these were to pharmaceutical or medical device manufacturers for cGMP violations.

Find those eight Warning Letters at
http://www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip
Use information from these Warning Letters to reinforce your GMP training efforts. Warning Letters can make for good case studies and can trigger meaningful discussion during training sessions.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1069 clients since 1996

Our next GMP Boot Camp is April 18 - 19
in Anaheim California. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

Our next Statistics Boot Camp is May 23 - 24 in Washington DC.
Introduction to Statistical Methods for FDA Regulated Industries

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Analyzing Customer Complaints - March 5, 2007

2007-03-05T13:49:00.000-08:00

In our workshops, we often challenge the participants with the following question – “Are customer complaints good news or bad news?”

The answer is “Yes.”

The bad news part is something’s amiss. The good news part is that the customers who take the time to complain are giving us two things. 1) They’re giving us a second chance to keep them as customers. 2) They’re giving us valuable data on what needs to be improved.

Note: The vast majority of unhappy customers don’t even complain - they just go somewhere else. We’ve lost them as customers.

When we do get feedback in the form of complaints, the big question is “What do we do with it? Do we analyze it for trends or patterns? Do we make appropriate changes to our systems and processes to prevent those problems from occurring in the future?”

This is exactly what FDA expects us to do with complaint data. Here’s an excerpt from a Warning Letter recently issued to Edwards Life Sciences LLC.

“There is no documentation that the numerous open complaints from 2000 to the present were analyzed to identify existing and potential nonconforming product, or to determine whether corrective and preventive actions were necessary.”

Read the entire 8 page Warning Letter. Go to:
http://www.gmptrainingsystems.com/asp/resources.asp
Scroll down to Timely Resource Articles

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1063 clients since 1996

Our next GMP Boot Camp is April 18 - 19
in Anaheim California. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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Ex-FDA Commissioner sentenced - Feb 28, 2007

2007-02-28T09:32:00.000-08:00

Former FDA Commissioner Lester Crawford was sentenced to three years' supervised probation with fines of roughly $90,000 for lying about stocks he owned in companies regulated by the FDA while he was Commissioner. Crawford pled guilty in October to charges of having a conflict of interest and false reporting of his stock records.

Don't we teach in GMP training that falsifying records will get you fired and sometimes even prosecuted? Guess Mr. Crawford wasn't practicing GMP.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1057 clients since 1996

Our next GMP Boot Camp is April 18 - 19
in Anaheim California. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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Cardinal Health signs Consent Decree - Feb 20, 2007

2007-02-20T10:04:00.000-08:00

FDA announced that Cardinal Health 303 Inc. formerly known as Alaris Medical Systems, Inc., and three of its top executives, have signed a consent decree for condemnation and permanent injunction related to their Signature Edition (SE) infusion pumps.

Cardinal Health 303 Inc. has agreed to stop manufacturing and distributing all models of the SE infusion pumps until they correct manufacturing deficiencies and until the devices are made in compliance with the current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for medical devices.

Read FDA’s announcement and the actual Consent Decree.
Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

This is David Markovitz, President of GMP Training Systems, Inc. Surely you heard about the recall of Peter Pan Peanut Butter last week. I checked our pantry at home and found 5 jars with the code listed in the recall. This recall really hit home for us. 5 jars? Yes, we like peanut butter in our house (Peter Pan WAS our favorite).

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1054 clients since 1996

Our audio seminar series - Reversed-Phase HPLC
Method Development: Generate Better Methods Faster –
is starting on March 2. Learn more at:
www.gmptrainingsystems.com/asp/lc_series_070302.asp

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FDA Whistleblowers Help Congress - Feb 13, 2007

2007-02-13T11:41:00.000-08:00

Scientists who have worked at the U.S. Food and Drug Administration and criticized agency decisions are now helping Congress fashion legislation to tighten product-safety rules.

The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.

Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules.

Be prepared for tougher FDA inspections as a result of actions like this.

Read the rest of this article: Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1051 clients since 1996

Last chance to register for our GMP Boot Camp.
February 21 - 22 in Hampton, VA. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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FDA 's Budget up 5% - Feb 6, 2007

2007-02-06T15:55:00.000-08:00

The President’s FY 2008 Budget includes a 5 percent increase for FDA over the budget submitted to Congress last year. FDA's portion of the federal budget is $2.1 billion.

This means a bigger FDA next year to keep us on our toes.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1047 clients since 1996

Our first GMP Boot Camp in 2007 is filling up fast.
February 21 - 22 in Hampton, VA. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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FDA's Consumer Safety Officers - Jan 29, 2007

2007-01-29T14:07:00.000-08:00

Ever wonder about the qualifications of the FDA investigators? The official job title is Consumer Safety Officer. This position is the frontline position of the FDA. CSOs are stationed at over 200 locations throughout the US.

Read the official job description. Go to
www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1043 clients since 1996

Our first GMP Boot Camp in 2007 is filling up fast.
February 21 - 22 in Hampton, VA. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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45 Years of CGMPs - Jan 23, 2007

2007-01-23T06:34:00.000-08:00

This year marks the 45th anniversary of the birth of CGMPs. These regulations have reached middle age and are still evolving. Dr. Suzanne White Junod, FDA Historian, wrote an interesting article about the beginnings of CGMP, entitled "God, Motherhood and the Flag" Implementing the First Pharmaceutical Current Good Manufacturing Practices (CGMP's) Regulations

To read this article, go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1041 clients since 1996

Our first GMP Boot Camp in 2007 is filling up fast.
February 21 - 22 in Virginia Beach, VA. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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FDA Halts Sales at Medical Device Company - Jan 15, 2007

2007-01-15T15:41:00.000-08:00

GE OEC Medical Systems signed a consent decree with FDA which prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, UT, and Lawrence, MA.

This action follows a Warning Letter issued to the company in March 2005. Here's one excerpt from the Warning Letter.

"Our inspection disclosed that your firm discovered that test technicians were not completing original test procedure documentation (Process History Records), but instead were copying test results from one device to another for a period of at least one year."

"Not only were test technicians found to be using photocopied device test results as noted above, but supervisory staff and management who reviewed and signed off on these records never caught this practice which occurred for at least one year."

Read the entire Warning Letter, FDA's Press Release announcing the Consent Decree, and a newspaper account of this action. Go to:
http://www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1039 clients since 1996

Our first GMP Boot Camp in 2007 is filling up fast.
February 21 - 22 in Virginia Beach, VA. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.asp

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