Validation Master Plan - The Unwritten Requirements 2019 is an event dedicated to the major cGMP deficiencies and "must have" elements .
Validation Master Plan - The Unwritten Requirements 2019 covers topics such as:
- Verification or Validation - Recent regulatory expectations
- The Individual V&V Plan
- The Master Validation Plan
- When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
- Product V&V versus Process / Equipment V&V
- The 11 Elements of the Software VT&V "Model"
- Using the Risk Management tools of ISO 14971 and ICH Q9
- Key recent compliance problems
Validation Master Plan - The Unwritten Requirements 2019 intended for:
- Senior management
- Quality Assurance
- Regulatory Affairs
- Engineering, including Software
- Production
- All personnel involved in verification and/or validation planning, execution and documentation.
