Duration: 75 Minutes


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With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic evaluation, vendor agreements, incident management and structured back-up. Just in the last three years more than 30 warning letters mentioned violations for computer systems, some of them with disastrous consequences for the companies. Most companies have a computer validation and Part11 compliance program in place, but either it is wrongly designed, not implemented or not followed.

Reference material for easy implementation:

  • SOP Auditing Computer Systems
  • Part 11 checklist
  • Checklist

Areas Covered in the Session :

  • FDA regulations and guidelines
  • 10 most frequently found deviations and how to avoid them
  • Developing an SOP for audits of computer systems.
  • Effective development and use of audit checklists
  • Conducting the audit: review procedures, walk through the computer system area
  • Most critical computer system questions to ask: traditional and new ones
  • Auditing for data integrity
  • Documenting detailed audit findings
  • The audit summary report
  • Auditing in preparation for FDA’s new Part 11 initiative
  • Case study: going through a life audit

Who Should Attend:

  • IT Departments
  • QA Departments
  • Operations Departments
  • Users of computer systems in regulated areas
  • Analysts and lab managers
  • Validation specialists
  • Training Departments
  • Documentation Departments
  • Consultants

Course Director: DR. LUDWIG HUBER

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), 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”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).