This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
This training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on Part 11 validation. It will discuss the common compliance problems with spreadsheets and how you can avoid them. Attendees will also learn about documentation for Part 11 compliance and future trends in compliance for Excel spreadsheets.
Why Should You Attend:
Spreadsheet applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 Compliance . However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel spreadsheet applications is required as part of a 21 CFR 11 compliant environment.This training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on Part 11 validation. It will discuss the common compliance problems with spreadsheets and how you can avoid them. Attendees will also learn about documentation for Part 11 compliance and future trends in compliance for Excel spreadsheets.
Areas Covered in the Webinar:
- Requirements for Excel Spreadsheets
- FDA Part 11 Validation Guidance
- Compliance Problems with Spreadsheets
- Design Specifications for 21 CFR 11 Compliance
- Documentation for Part 11
- Future Trends in 21 CFR 11 Compliance for Excel Spreadsheets
Who Will Benefit:
- Regulatory VP
- Quality VPs
- IT VPs
- Regulators
- Regulatory Affairs professionals: Quality Managers, Quality Engineers, Small business
- Owners, GxP Consultants
Course Provider
Angela Bazigos,
