Description:In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.Course Objective: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.Course Outline:Requirements for Excel SpreadsheetsFDA Part 11 Validation GuidanceCompliance Problems with SpreadsheetsDesign Specifications for 21 CFR 11 complianceDocumentation for Part 11Future Trends in 21 CFR 11 compliance for Excel SpreadsheetsTarget Audience:Quality ManagersQuality EngineersSmall business ownersGxP ConsultantsQuality VPsIT VPs