Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements 2019

Topics

• 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"

Who should Attend

• Regulatory Affairs
• Senior management
• Production
• Quality Assurance
• All personnel involved in verification and/or validation planning, execution and documentation
• Engineering, indluding Software