Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management allows the development of meaningful product and process validations. 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, against a background of limited company resources.  Our matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are also considered. Formal ISO and CGMP definitions vs. “working definitions”. The end result of this webinar will be a format for a working V&V system, field-tested over decades, for all regulated industries, and US FDA CGMP and EU compliant.

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big-name device and pharma companies. One major failing is lack of sufficient or targeted risk-based V&V planning and execution. But a review of Internet forums shows confusion as to what is V&V planning. What really is a Master Validation Plan? Why do companies need one? What are the individual V&V plan and its high value? What are verification activities? Validation? Qualifications? IQ, OQ, PQs? Commissioning? FAT, SAT? How to translate Requirements into IQ, QO, and PQ test cases/scripts. What are the "must have" elements from  ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated?