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

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

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