Jeff Boatman
Instructor Jeff Boatman
Product Id 600418
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

FDA's 2011 Guidance on Process Validation - General Principles and Practices


Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard.

While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U.S. drug. API, and biologics process validation up to par with the advanced and modern expectations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics industries (or their vendors!) can afford to miss this presentation; while validation personnel in the medical device, tissue processing, and dietary supplement fields will find it informative and useful.

Why should you attend: FDA has stated that the principles in the new guidance are directly supported by regulation, law, and current best practices, and expects to begin issuing 483s immediately. While the medical device industry has been subject to many of the requirements in the new guidance, most pharmaceutical firms and their suppliers have not implemented, and may not even fully understand, the advanced statistical, scientific, and management expectations now demanded by FDA with the release of this standard.

Areas Covered in the Session:

  • Specific discussions include
  • Background of the original guidance, its history, application, and items covered
  • FDA regulatory authority
  • Growth of competing standards and the competing expectations of the medical device industry
  • The history and philosophy of the new guidance
  • The three stages of the new guidance, their sequence, and interrelationship
  • Role of risk management, statistical controls, and GMP requirements
  • Associated and predicate testing, qualifications, and vaildations
  • Analytical and recordkeeping expectations
  • Opportunity for accelerated release of commercial product
  • Differences between the old and new standards, and the draft and final
Who Will Benefit:
  • Validation specialist
  • Validation engineer
  • Process engineer
  • Internal Auditors
  • Validation manager
  • Compliance manager
  • Regulatory specialist
  • Vendor Auditors
  • Quality Engineer

Speaker Profile
Jeff Boatman is a Quality Systems Subject Matter Expert at QPharma, a regulatory and compliance consulting firm in Morristown, N.J. With 23 years in the medical device and pharmaceutical industries, Mr. Boatman has worked in virtually every aspect of life science engineering, from laboratory supervisor, manufacturing engineer, R&D, and quality and compliance management. He is a frequent speaker at industry conferences and was selected by PharmaVoice Magazine as one of 2010's "100 most influential people" in the drug industry. Mr. Boatman graduated from the College of the Air Force in 1981 with a degree in Nuclear Physics.

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