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Understanding and Preparing for FDA New Part 11 Inspection Program
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.
This seminar will give a good understanding of the FDA inspection program and will help attendees to prepare them for the inspections. The speaker will give very detailed information on the FDA program and answer all questions above and more. He also will provide information on FDA's expectation how Part 11 requirements should be implemented.
Areas Covered in the Seminar:
- FDA inspections:
- 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
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .
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