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

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

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

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

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

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

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.