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2020 - The 6 Most Common Problems in FDA Software Validation and Verification
Date2020-11-27
Deadline2020-10-17
VenueOnline event, USA - United States 
KeywordsPart 11; Annex 11; Validation
Topics/Call fo Papers
Which data and systems are subject to 21 CFR Part 11 and Annex 11
Why compliance makes good business sense.
Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
Requirements for local, SaaS, and cloud hosting
The 6 Most Common Problems in FDA Software Validation & Verification.
Strategies on how to avoid the most common problems.
Advice on successful validation project staffing.
Avoid 483 and Warning Letters
Why compliance makes good business sense.
Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures.
Requirements for local, SaaS, and cloud hosting
The 6 Most Common Problems in FDA Software Validation & Verification.
Strategies on how to avoid the most common problems.
Advice on successful validation project staffing.
Avoid 483 and Warning Letters
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Last modified: 2020-09-29 21:31:14