Topics
- 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
Who should Attend
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
- Validation specialists
- IT / IS managers and personnel
- Consultants
- Software quality reviewers
