Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements 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
Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements brings together QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants and Operations.
