Upcoming Events at Online
Aug 10, 2018 | 10:00 AM | Friday
Neighborhood: Upper West Side
However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter.
Fri Aug 10, 10:00 AM - Fri Aug 10, 11:30 AM
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.
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
Who Will Benefit:
Small Business Owners
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.
Event Fee: One Dial-in One Attendee Price: US $150.00
Compliance4All DBA NetZealous,
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