DVD – multi-user single site: GMP Training for Drugmakers

August 2014
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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.

·   Introduction to FDA GMP regulations

·   Organization and Personnel, 21 CFR 211.22-211.34

·   Buildings and Facilities, 21 CFR 211.42-211.58

·   Equipment, 21 CFR 211.63-211.72

·   Control of Components and Drug Product Containers and Closures, 21 CFR 211.80-211.94

·   Production and Process Controls, 21 CFR 211.100-211.115

·   Packaging and Labeling Control, 21 CFR 211.122-211.137

·   Holding and Distribution, 21 CFR 211.142-211.150

·   Laboratory Controls, 21 CFR 211.160-211.176

·   Records and Reports, 21 CFR 211.180-211.198

·   Returned and Salvaged Drug Products, 21 CFR 211.204-211.208

·   Putting GMPs Into Practice