This Part 11 Inspection training will answer all questions related to the new part 11 inspection program by FDA and FDA expectation of implementing part 11 requirements.
Areas Covered in the Seminar:
- FDA inspections: Preparation, conducts, follow up.
- Scope of the new Part 11 program: time frame, expected outcome.
- Criteria for selection of target companies.
- What will inspectors be 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.
For easy implementation, attendees will receive
- Part 11 Checklist
- Part 11 Compliance 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) with deviations related to computer systems and Part 11 compliance.
Who Will Benefit:
- Pharmaceutical and medical device industry.
- Manufacturers of pharmaceutical ingredients.
- Contract manufacturers and laboratories.
- IT managers and system administrators.
- Part 11 project managers.
- QA managers and personnel.
- QC and Lab managers
- Validation specialists.
- Regulatory affairs.
- Training departments
- Documentation department
For More Information: