GMP Training for Drugmakers

GMP Training for Drugmakers

February 2014

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

BONUS: In addition to the video presentation you’ll get second disc packed with hundreds of pages of valuable resources, including:

  • Regulations — 21 CFR Parts 210 and 211
  • Guidance for Industry — Quality Systems Approach to Pharmaceutical CGMP Regulations
  • Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach
  • Q7A — Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
  • Q10 — Pharmaceutical Quality System
  • FDAnews Management Report — A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance
  • Presentation Slides
  • Regulatory affairs/compliance staff
  • Quality control/assurance managers
  • Chief executives, especially Operations
  • Line managers
  • Training staff

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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