GMP Tips

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 [...]

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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 CASEOn 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 [...]

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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 [...]

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