In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.

Why Should You Attend:

FDA Warning Letters and recalls indicate major cGMP deficiencies in device and pharma companies on both sides of the Atlantic. One major failing is lack of sufficient or targeted risk-based V&V planning. And confusion over what the term "risk-based really means. Aa review of Internet forums shows confusion as to what is risk and what is V&V planning. What is the VMP and the individual V&V plan and there formats and roles. What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated? Mandatory risk for Software / firmware V&V.

This webinar will review company's Validation Master Plan for major cGMP deficiencies. Review hazard and risk management tools per ISO 14971 and ICH Q9. Utilize sufficient or targeted risk-based V&V planning. Use the VMP and Product Risk Management Files to develop meaningful product and process validations. Address "worst case allowables". Also the role of the individual V&V plan, and different protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. The models presented simplify "as-product", in-product", process and equipment, software VT&V, assuring key FDA requirements are not overlooked. V&V of a company's QMS and 21 CFR Part 11 are considered.