Thursday, October 27, 2005

FDA Recall Data FY 2005

While presenting at IVT's Validation Week Annual Conference, David Markovitz, President of GMP Training Systems, took the opportunity to attend a presentation by Kristen Evans, an FDA Compliance Officer. Mr. Evans presented the Top Ten reasons for recalls overseen by the Center for Drug Evaluation and Research (CDER).

The Number One reason by a HUGE margin was cGMP Deviations.

This is more evidence that we need to do a better job in our GMP training. There were 144 recalls last year (FDA's fiscal year Oct 04- Sept 05) due to cGMP deviations (41% of all recalls). The number two reason was failed USP dissolution with 55 recalls.

To see the entire list of recall reasons, go to http://www.gmptrainingsystems.com/asp/articles.asp
Scroll down to FDA Resources.

Incidentally, after seeing David's presentation as Teddy Roosevelt - The Evolution of Food and Drug Law from the 19th Century to the 21st Century - Kristen Evans invited David to conduct this presentation for the FDA. He said, "Everyone working for FDA needs to experience your presentation."

You can learn more about this presentation at http://www.gmptrainingsystems.com/asp/evolution.asp

GMP Training Systems
Experience you can Trust!
www.GMPTrainingSystems.com

Monday, October 17, 2005

FDA Seizes Pumps

Here's an incident you can use to reinforce the need to comply with GMP. This case demonstrates the power FDA has and their willingness to use it.

THE CASE
On October 12, 2005, a US District Court, working with the FDA, issued a warrant for seizure of infusion pumps manufactured by Baxter Healthcare Corporation. Four thousand pumps were seized by the US Marshals Service from a Baxter warehouse, and 135 pumps were seized from a distributor's warehouse.


FDA inspections revealed that the firm has continually failed to follow medical device manufacturing requirements in the manufacture of these pumps. Baxter was previously issued Warning Letters outlining the violations and was given an opportunity to correct the violations, but failed to take appropriate actions.

"This case demonstrates that the FDA will take the necessary steps to protect America 's public health," said Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs. "Today's notification shows our commitment to informing the public about important safety issues."


Read FDA's Press Release at http://www.gmptrainingsystems.com/asp/articles.asp

What might be the business consequences this company faces as a result of this action?

This is a good question to use when using this case in a GMP training session. Place people in small groups and have them discuss this question for 5 minutes or so. Then debrief each group - have them share their findings - with the entire class.

The key wrap-up question then becomes:
"Which is easier and less costly? Dealing with the issues of the product seizure, or complying with GMP in the first place?"

www.GMPTrainingSystems.com

We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our next two-day public seminar, Fundamentals of GMP/QSR is scheduled for November 16-17 in Anaheim, CA. Ideal for people new to the industry.

Monday, October 10, 2005

Interactive Activities

One proven method for generating interest in compliance issues during training sessions is through the use of interactive activities.

Did you know that the FDA has prepared a series of quizzes that are available on their website?

Go to http://www.fda.gov/fdac/quiz/quiz_archive.html for a listing of these quizzes.

Here's how you can use these quizzes in your GMP training.

  • Use them as prepared by FDA.
  • Take the questions from these quizzes and create your own quiz to use. Mix and match the various questions from the different quizzes.
  • Distribute a quiz to people as they arrive in the training room before the training starts. They can work on them as they are waiting for the session to begin as an informal warm-up exercise.
  • Set people up in pairs or teams of threes. Let them work on the quiz together.
  • Establish friendly competitions between groups to see who can get the most answers correct. Have small prizes like candy bars avaiable for the winners. (I like to also have on hand smaller candy bars for everyone else.)

www.GMPTrainingSystems.com

We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.