6 Most Common Problems in FDA Software Validation and Verification

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
  • Validation specialists
  • IT / IS managers and personnel
  • Consultants
  • Software quality reviewers

Future Events

6 Most Common Problems in FDA Software Validation and Verification 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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