Computer System Validation: Step-by-Step

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.

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Why Should You Attend:

The validation of computer systems has been an FDA requirement for over 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, particularly when it comes to development of protocols. This webinar will provide attendees a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. It will also detail the structure of a validation plan with examples.


For easy implementation, attendees will receive:

  • SOPs: 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 Webinar:
  • US FDA and EU requirements and enforcement practices
  • Learning from recent FDA 483s 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
  • Examples of 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 units for easy implementation
Who Will Benefit:
  • Personnel from the pharmaceutical and medical device industry
  • Manufacturers of pharmaceutical ingredients
  • Contract manufacturers and laboratory staff
  • IT managers and system administrators
  • QA managers and personnel
  • QC and lab managers
  • Validation specialists
  • Regulatory affairs personnel
  • Training department personnel
  • Documentation department personnel
  • Consultants
Instructor Profile:
Dr. Ludwig Huber Dr. Ludwig Huber

Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of, 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 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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