6 Most Common Problems in FDA Software Validation and Verification is a webinar that covers topics such as:
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
6 Most Common Problems in FDA Software Validation and Verification is intended for attendees from FDA regulated Medical Device, Pharmaceutical, Diagnostics, Biotech and Biological manufacturers, including:
QA / QC managers, executives and personnel
System owners - responsible for keeping individual systems in validation