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

Verification or Validation -- Current regulatory expectations.
The Master Validation Plan and the Individual V&V Plan.
What is "risk-based"?
Product V&V versus Process / Equipment V&V versus QMS V&V
When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
Using the Risk Management tools of ISO 14971 and ICH Q9
The 11 Elements of the Software VT&V "Model"
Key recent compliance problems