DAY 1 (10 AM to 4 PM)- V&V Planning; The Master Validation Plan; The Individual Validation Plan
- “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 4 th , Software); also GAMP / JETT approaches
- V&V Project Management – “Milestones” and “Tasks”
- 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”
Elements of a V&V File / Protocol:- Intro / Purpose / Scope
- Protocol Material / Equipment
- DQ or Requirements Specs
- ASTM2500
- IQ (or equivalent)
- OQ (or equivalent)
- PQs (or equivalent)
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| DAY 2 (10 AM to 4 PM)- Develop and Employ Meaningful V&V Files and Protocols for:
- Products;
- Process;
- Production Equipment;
- Monitoring and Test Equipment;
- Software;
- Quality Management System – 21 CFR 11, Electronic Records / Signature
- The FDA’s 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
- V&V, Senior Management / IP and Limited Company Resources
- U.S. FDA Audit Issues and “Responsible” Documentation
- Interactive Discussions and Q&A Session
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