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21 CFR (11) Compliance For Excel Spreadsheets: 2013 & Beyond
Friday, March 22, 2013 from 10:00 AM to 12:00 PM (PDT)
Palo Alto, CA
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Partet 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 2-hr training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on Part 11 validation. We 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 Seminar:
- 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.
Date: March 22, 2013
Time: 10:00 AM-12:00 PM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.