Risk-Based Software V&V - FDA,GAMP®, 14971

One major failing is lack of sufficient or targeted risk-based software V&V planning. Starting with a Project Validation Plan, evaluating its elements against ISO 14971:2007 hazard analysis / risk management, allows development of meaningful product / process validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). Two matrices / models simplify regulatory requirements for "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

Areas Covered in the seminar:

• Verification or Validation -- Recent Regulatory Expectations.
• The Project Validation Plan.
• Software Product Validation - how it differs from process / equipment V&V.
• When and How to use DQ, IQ, OQ, PQ?
• How to use your Risk Management Tools (per ISO 14971:2007)?
• GAMP® guidance.
• The 11 "must have" elements of software validation.
• White box and/or "black box".
• Some "real world" test case examples.

Who will benefit:

• All Management Levels.
• Project Leaders.
• Regulatory Affairs.
• Quality Systems Personnel.
• R&D and Engineering Staff.
• All charged with new product / pilot development, regulatory submissions, initiating / overseeing company-wide software / V&V planning, using an ISO 14971:2007-based risk-justified approach.
• CAPA and P&PC personnel desiring to minimize post-production / life cycle and other costly problems.

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org

Instructor Profile:
John E. Lincoln, Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association); he publishes a newsletter. He is a graduate of UCLA.