Topics
- FDA Part 11 Validation Guidance
- Requirements for Excel Spreadsheets
- Design Specifications for 21 CFR 11 compliance
- Compliance Problems with Spreadsheets
- Future Trends in 21 CFR 11 compliance for Excel Spreadsheets
- Documentation for Part 11
Who should Attend
QA/ QC, Regulatory Affairs, Software Managers, IT/IS and Project Managers.
