Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements 2019 is a webinar that covers topics such as:
- The Master Validation Plan and the Individual V&V Plan
- Verification or Validation -- Current regulatory expectations
- Product V&V versus Process / Equipment V&V versus QMS V&V
- What is "risk-based"?
- Using the Risk Management tools of ISO 14971 and ICH Q9
- When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
- Key recent compliance problems
- The 11 Elements of the Software VT&V "Model"
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements 2019 is intended for:
- Regulatory Affairs
- Senior management
- Production
- Quality Assurance
- All personnel involved in verification and/or validation planning, execution and documentation
- Engineering, indluding Software
