Topics
- The Project Validation Plan
- Verification or Validation -- FDA Expectations
- Product and Process / Test / Facilities / Equipment Software V&V
- An FDA-accepted Documentation "Model"
- GAMP / Other Considerations
- When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
- "White Box" and "Black Box" Validations
- The FDA`s 11 Key V&V Documentation Elements
Who should Attend
QA / RA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, Software development, programming, documentation, testing teams, Production, Engineering, Consultants; others tasked with product, process, electronic records software V&V responsibilities and Operations.
