The Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements 2015 is a webinar that covers topics such as:
- The Master Validation Plan / structure
- Verification or Validation - Recent regulatory expectations
- Process / Equipment / Facility Validation - FDA`s new guidance
- Product Validation - how it differs from process / equipment V&V
- How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
- When and How to use DQ, IQ, OQ, PQ, or their equivalents
- Incorporating 21 CFR Part 11 requirements
- The 11 key documents for software validation
- Suggested "test case" formats
The Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements 2015 is intended for:
- QA
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- R&D
- RA
- Production
- Engineering
- Consultants; others tasked with product, process, software... validation responsibilities
- Operations
