Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections.
Planned routine inspections will be extended to evaluate the companies` practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional `for cause inspections`. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry.
Reference material for easy implementation: - 25 recent FDA Warning Letters with part 11 violations.
- 15 Case Studies: Implementing Part 11
- Validation templates and examples
Areas Covered In the Seminar: - FDA inspections: Preparation, conducts, follow up
- Learning from past Part 11 inspections
- Scope of the new Part 11 program: time frame, expected outcome
- Criteria for selection of target companies
- What inspectors are looking for
- How to prepare your company for the upcoming inspections
- Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations
- How to fill gaps short term
- Developing a program for long term
- Creating the right documentation to satisfy the inspectors
- Most likely next steps after the inspection program
Who will benefit: - IT managers and system administrators
- QA managers and personnel
- QC and Lab managers
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
