A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures is a webinar that covers topics such as:
- Current Regulatory Expectations and Recent Audit "Hot Buttons"
- Verification or Validation
- The Simplified Approach to 21 CFR Part 11 Compliance and Software V&V
- The Part 11 Project Validation Plan
- Simplified Sample V&V Test Cases and their Development
- When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
- GAMP / Other Considerations
- The FDA`s 11 Key V&V Documentation Elements
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures brings together QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants; others tasked with CGMP process and electronic records / signatures software V&V responsibilities and Operations.
