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Excel Spreadsheet Validation for FDA 21 CFR Part 11
Product Id
:
601108
Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
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.
Areas Covered in the Session:
Who Will Benefit:
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.
Areas Covered in the Session:
- Requirements for Excel Spreadsheets
- FDA Part 11 Validation Guidance
- Compliance Problems with Spreadsheets
- Design Specifications for 21 CFR 11 compliance
- How does the FDA Design and Use spreadsheets
- Documentation for Part 11
- Future Trends in 21 CFR 11 compliance for Excel Spreadsheets
Who Will Benefit:
- Quality Managers
- Quality Engineers
- Small business owners
- Internal and external auditors
- Management Reps
- FDA inspectors
- Consultants
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