Computer System Validation: Step-by-Step

The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.

For easy implementation, attendees will receive

  • SOP: Validation of Commercial Off-the-Shelf Computer Systems
  • SOP: Development and Maintenance of Test Scripts for Software and Computer Systems
  • Checklist: Using computers in FDA regulated environments
Areas Covered in the Session :

  • US FDA and EU requirements and enforcement practices
  • Learning from recent FDA 483’s and warning letters
  • Selecting the right validation model: qualification vs. verification
  • Eight fundamental steps for computer system validation
  • Structure and example of a validation plan
  • Justification and documentation of risk levels
  • Example qualification document for suppliers of commercial systems
  • Examples for requirement and functional specifications?
  • Example for IQ protocols
  • OQ test protocols: development, execution, approval – examples
  • Documentation of ongoing performance
  • Validation of existing systems
  • Structure and example of a validation report
  • Step-by-step case studies from laboratories and manufacturing for easy implementation
Who Should Attend:

A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of pharmaceutical ingredients and Contract manufacturers and laboratories. The teams that will benefit the most are:

  • IT Departments
  • QA Departments
  • QC Lab Departments
  • Validation Specialists
  • Regulatory Affairs Departments
  • Training Departments
  • Documentation Departments
  • Consultants

FDB1958

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).

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance