Verification and Validation - Product, Equipment/Process, Software and QMS

Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning: Start with a Master Validation Plan; Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management; The Individual V&V Plan; V&V Project Management; “Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT; Two key input analysis tools; Change control and “drawing a line in the sand”; Develop meaningful V&V Files and Protocols for: Products; Process; Production Equipment; Monitoring and Test Equipment; Software; Quality Management System – 21 CFR 11, Electronic Records / Signatures; The roles of different V&V protocols; How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, V&V against a background of l... Read more

Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning: Start with a Master Validation Plan; Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management; The Individual V&V Plan; V&V Project Management; “Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT; Two key input analysis tools; Change control and “drawing a line in the sand”; Develop meaningful V&V Files and Protocols for: Products; Process; Production Equipment; Monitoring and Test Equipment; Software; Quality Management System – 21 CFR 11, Electronic Records / Signatures; The roles of different V&V protocols; How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, V&V against a background of limited company resources; The FDA's 11-element software matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V; Assure key U.S.FDA and comparable EU MDD / ISO requirements are not overlooked; The QMS and 21 CFR Part 11, “Electronic Records / Signatures” V&V; Hands-on examples and activities show real-world implementation of useful principles, tools and templates; Learning Objectives: Understand Verification and Validation, differences and how they work together Develop a “Working Definition” of V&V, Qualification, and related terms Discuss recent regulatory expectations How to document a “risk-based” rationale, and use it in a resource-constrained environment Determine key “milestones” and “tasks” in a project; device sample provided Locate and document key subject “inputs” Compile “generic” Master and Individual Validation Plans Lean the key element of a Product V&V File / Protocol How to develop Process and/or Production / Test Equipment V&V Files / Protocols Basic Test Case / Script construction Sample sizes and their justification Lean the key 11 elements of Software V&V expected by the FDA and how to document See how to compile QMS Electronic Records and Electronic Signatures V&Vs per 21 CFR 11 and related CGMPs Who will Benefit: This seminar 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: Senior and middle management and staff Regulatory Affairs QA/QC IT/IS R&D Production Management Manufacturing Engineers Process Engineers Software Engineers Project Managers Hardware and software vendors, sales and marketing