Excel Spreadsheets for 21 CFR 11 Compliance

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Category Quality Managers, Quality Engineers, Small Business Owners

Deadline: December 10, 2018 | Date: December 12, 2018

Venue/Country: Online, U.S.A

Updated: 2018-11-13 17:56:54 (GMT+9)

Call For Papers - CFP

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

Documentation for Part 11

Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Who Will Benefit

Quality Managers

Quality Engineers

Small Business Owners

GxP

Consultants

Quality VPs

IT VPs

Speaker Profile

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.