Meeting date: February 7, 2023, 11: 00 AM ET
Since the release of the FDA draft on Computer Software Assurance (CSA), September 13th, 2023, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. The FDA, FICSA and CG will have an open discussion around the implications and opportunities that may impact the 21 CFR Part 11 while applying CSA methodology. This webinar will cover the following topics:
- The Myth Vs Fact that CSA may compromise the quality of computerized systems
- Being compliant with 21 CFR Part 11 in 2023 versus 1997 – Regulation did not change
- Shift away from matching the phraseology of the regulations to meeting the intent of the regulations
- Leveraging the best technology to ensure authenticity, integrity and the confidentiality of electronic records
