Review a company`s Master Validation Plan for significant cGMP deficiencies. Address the FDA`s newer and tougher regulatory stance. One major failure is the 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, QoS, and PQs, or their equivalents, against a background of limited company resources. Our matrix simplifies "as-product", in-product", process and equipment, and software VT&V, assuring essential FDA requirements are not overlooked.
The QMS and 21 CFR Part 11 are considered.
Background:-
Both the U.S. FDA . Pharma, and EU`s MDR expect documented risk-based "master" and "individual" V&V planning
Why Should You Attend:-
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big-name device and pharma companies. One major failure is the lack of sufficient or targeted risk-based V&V planning. 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 their high value? What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated?
Who Should Attend:-
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on Medical Devices, its principles apply to personnel/companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
