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.
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:Quality ManagersQuality EngineersSmall Business OwnersGxP ProfessionalsConsultantsQuality VPsIT VPs