Monday, June 30, 2008

GMP Tips - Effective Written Procedures - June 30, 2008

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.

Tuesday, June 24, 2008

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

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.

Sunday, June 15, 2008

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

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.

Monday, June 09, 2008

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

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.

Monday, June 02, 2008

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

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.