Topics
- Current Regulatory Expectations and Recent Audit "Hot Buttons"
- Verification or Validation
- Product and Process / / Facilities / Equipment Software V&V
- The Project Validation Plan
- GAMP / Other Considerations
- When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
- CFR Part 11, QMS, Electronic Records / E-Signatures
- The FDA’s 11 Key V&V Documentation Elements
- "White Box" and "Black Box" Validations
Software Verification and Validation Planning to Meet FDA Requirements brings together QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants; others tasked with product, process, electronic records software V&V responsibilities and Operations.
