ComplianceOnline

Understanding and Preparing for FDA's New Part 11 Inspection Program

Instructor: Dr. Ludwig Huber
Product ID: 701743
  • Duration: 93 Min

recorded version

$349.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$600.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

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.

Why Should You Attend:
Within the next few 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. There are many questions about the program and further steps: How are companies selected for the inspections?, Are 3rd party service providers part of the program, e.g., CROs? Will the outcome of inspections be made available to the public, e.g., through warning letters? When exactly will the program start and how long will it last? How many inspections will be part of the program? Could preclinical (GLP) studies be part of the program? Will there be a dedicated Part 11 inspection team? Are inspectors trained on what to look specifically? It seems, that record integrity is a key issue, Is there a standard how records are protected ? Will inspections take longer because of Part 11? What are the recommendations for clinical record systems? How will the program impact inspections of Medical Device manufacturers? And many more...

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: 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.

Hand-Outs:

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
  • Consultants

Instructor Profile:
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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