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
