A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures 2011
24 Aug 2011
Webinar
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.
Past Events
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures 2011 - 24 Aug 2011, Webinar (17835)
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures 2026
Important
Please, check "A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11, Electronic Records, Signatures" official website for possible changes, before making any traveling arrangements
