Pharmaceutical, Diagnostic, and Biologics Product, Equipment/Process, Software and QMS Verification and Validation Training Course - ResearchAndMarkets.com
Summary
DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.coms offering. One major failing is lack of sufficient or targeted risk-based V&V planning: • Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management; • Change control and "drawing a line in the sand"; • The roles of different V&V protocols; • How to employ equipment/process DQs, IQs, OQs, and PQs, or their equivalents, • The FDAs 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; • Hands-on examples and activities show real-world implementation of useful principles, tools and templates; • Understand Verification and Validation, differences and how they work together • How to document a "risk-based" rationale, and use it in a resource-constrained environment • 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 RAPS - This course has been pre-approved by RAPS as eligible for up to 9 credits towards a participants RAC recertification upon full completion. • "Risk-based" -- Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management - File Narrative, Hazard Analysis, FTA, 3 FMECAs (Design, Process, Use[r], and a possible 4th, Software); also GAMP/JETT approaches • Two key input analysis tools - The Process Map/Flow Chart, and the Cause and Effect Diagram (templates supplied) • Change control and "drawing a line in the sand" • Develop and Employ Meaningful V&V Files and Protocols for: • The FDAs 11-element software matrix simplifies "as-product", in-product", process and equipment software V&V - what they mean, how to research and how to document • The QMS, ERP and 21 CFR Part 11 V&V - "Cloud" Issues; "White box" and "Black box" Testing; Basic Test Case Development John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. Hes held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects.