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21 CFR (11) Compliance For Excel Spreadsheets: 2013 & Beyond
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.
Who Will Benefit:
- Regulatory Affairs
- QA/ QC
- Software Managers
- Project Managers
- Software vendors and suppliers
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in lifescience. She has received a patent for speeding up software compliance and has applied for patents aimed at speeding up software compliance and FDA software audits. She has co-authored “Computerized Systems in Clinical Research” with the FDA, DIA and Academia and teaches classes in project management, computer systems validation, quality assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanford’s Who’s Who for contributions to the LifeSciences industry.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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