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21 CFR Part 11 Compliance for Excel Spreadsheets

4117
Duration : 90 Minutes

Angela Bazigos,

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compl Read more


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. FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations.

Course Objectives:

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.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP Professionals
• Consultants
• Quality VPs
• IT VPs
• Regulatory Affairs professionals: Quality Managers, Quality Engineers, Small business
• Owners
• GxP Consultants

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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