Pharmaceutical manufacturers are required by the FDA to train personnel in FDA quality system requirements and procedures.
But, sending employees for training can be time-consuming and expensive. And it can be frustrating when an employee you’ve trained leaves you to go to work for a competitor — and you’re forced to start all over again.
But there is an easier way. Now you can train your staff yourself — for significantly less money, in your own office — with a new training video developed by a former FDA investigator, Seth Mailhot.
Seth has conducted hundreds of FDA inspections and in the new DVD, GMP Training for Drugmakers, he taps into his 14 years as an investigator to design a training program that gives you the kind of high-level employee education everyone needs and wants … with the flexibility that makes in-house training most beneficial.
Seth walks you through each of 12 GMP modules that can be viewed individually or all at once. This four hour DVD presents new and veteran employees alike a comprehensive view of the rules you must adhere to.
BONUS: In addition to the video presentation you’ll get second disc packed with hundreds of pages of valuable resources, including:
Seth Mailhot is a partner and lead of the FDA Regulatory Practice group in Michael Best & Friedrich LLP’s Washington, D.C., office. During his 14 years working in the FDA he served as an investigator and conducted numerous U.S. and foreign inspections.
Seth’s practice includes representation of pharmaceutical and dietary supplement makers, and covers both premarket and post-market GMP issues. Seth’s practice is focused on development of premarket submission strategies and FDA enforcement of good manufacturing practices, both domestically and abroad.
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