Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: John E. Lincoln
OVERVIEW:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must also be considered.
Why Should You Attend: Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased.
Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, are not documented in a top tier Master Validation Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.
Areas Covered in the Session:
– Verification or Validation – Recent regulatory expectations
– The Master Validation Plan and its structure
– Product Validation – how it differs from process / equipment V&V
– Process / Equipment / Facility Validation – including FDA’s recent guidance
– When and How to use DQ, IQ, OQ, PQ, or their equivalents
– How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
– The 11 key documents for software validation
– Incorporating 21 CFR Part 11 requirements
– Suggested “test case” formats
Who Will Benefit:
– Senior management in Drugs, Devices, Biologics, Dietary Supplements
– QA
– RA
– R&D
– Engineering
– Production
– Operations
– Consultants
SPEAKER PROFILE:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
