Auditing Computer Systems for FDA and International Compliance

Duration: 75 Minutes  


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Price: US$178.00

Dr. Ludwig Huber   Product Id : 500397
  Instructor : Dr. Ludwig Huber

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Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime.

In addition audits are also an excellent tool to prepare your organization and staff for external audits, e.g., FDA inspection.. However, without a clear strategy audits can become quite complex and ineffective. This seminar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

Reference material for easy implementation:

  • SOPs: Validation of Commercial Off-the-Shelf Computer Systems
  • Checklist: Using computers in FDA regulated environments
  • Validation templates and examples

Areas Covered in the Session:
  • Regulatory requirements: FDA, EU, PIC/S
  • Audit recommendations from the FDA Quality System guidance for cGMPs
  • Effective development and use of audit checklists
  • Developing an SOP for audits of computer systems.
  • Assigning responsibilities
  • Conducting the audit: review procedures, walk through the computer system area
  • Most critical questions to ask
  • Auditing for data integrity
  • Auditing in preparation for FDA's ongoing Part 11 initiative
  • Documenting detailed audit findings
  • The audit summary report
  • Effective follow up
  • Presenting evidence of the audit to the FDA
  • Case study: going through a life audit

Who Will Benefit:
  • QA managers and personnel
  • QC and Lab managers
  • IT managers and system administrators
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

Speaker Profile
Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website

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