FDA`s New Enforcement of 21 CFR Part 11 - Webinar By GlobalCompliancePanel 2011

  • 04 May 2011
  • Webinar

Description

Overview: FDA`s new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.

Just in 2007/2009, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that `enforcement discretion` as stated in the 2003 guidance is not applied any more. FDA`s computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies but industry needs more guidance and practical recommendations on how to respond to FDA`s new enforcement practice.

Areas Covered in the Session:
  • FDA`s current inspection and enforcement practices
  • FDA`s new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
  • Learning from FDA inspection reports
  • Part 11 and the new EU Annex 11: similarity and differences
  • Strategy for cost-effective implementation of the `new` Part 11:A six step plan
  • Recommended changes to existing Part 11 programs to reduce costs
  • Justification and documentation for the FDA and your management
  • 15 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
  • How to prepare for Part 11 Inspections

Who Will Benefit:
  • IT managers and System Administrators
  • QA Managers and Personnel
  • Analysts and Lab Managers
  • Validation Groups
  • Software Developers
  • Validation Professionals
  • Training Departments
  • Documentation Department
  • Consultants

Past Events

Important

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Event Categories

Education: Training
Health & Medicine: Hospitals & Clinics, Medical device, Medical laboratories, Pharma
Industry: Food & Beverages
Science: Laboratories
Technology: Information Technology (IT)

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