10:00 AM - 04:00 PM
Day 1

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)

10:00 AM - 04:00 PM
Day 2

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