On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences for inspected companies. This seminar will give an overview of FDA inspection findings and recommendations on how to avoid them.
For easy implementation, Attendees will receive:
- Part 11 Checklist
- Computer System Validation Master Plan
- Case Studies
- How to avoid Part 11 related 483`s and Warning Letters
- How to respond to Part 11 related 483`s and Warning Letters
- 30 FDA Warning Letters from 2007 to 2010 (Web downloads)
Areas Covered in the Session: - FDA inspections: Preparation, conducts, follow up
- The meaning of warning letters and 483 inspectional observations
- Learning from an FDA presentation: "Data Integrity and Fraud - Another Looming Crisis?"
- Data integrity and authenticity: FDA`s new focus during inspections of computer systems and e-records
- Examples of recent Part 11 related 483`s and Warning Letters
- Examples of recent 483` and warning letters related to computer system validation
- Most obvious reasons for deviations
- Responding to 483`s to avoid warning letters: going through case studies
- Writing corrective and preventive action plans as follow up to 483`s
- Strategies and tools for compliant Part 11 implementation
- FDA`s Part 11 Inspection Initiative 2010
