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FDA's New Enforcement of 21 CFR Part 11 - Webinar (Recorded)

  • Webinar

  • 75 Minutes
  • September 2018
  • NetZealous LLC
  • ID: 4594583
Overview:

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speakers

  • Ludwig Huber
  • Ludwig Huber,


Who Should Attend

  • QC Managers

  • QA Managers and Personnel

  • IT Administrators

  • Analysts

  • Regulatory Affairs

  • Training Departments

  • Documentation Department

  • Consultants