Computer System Validation: Step-by-Step

Instructor: Dr. Ludwig Huber
Product ID: 701673
Training Level: Advanced
  • Duration: 75 Min

recorded version

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

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: +1-650-565-8542


Read Frequently Asked Questions

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.

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

Note: These complimentary hand-outs will be sent to customers on request. Please email for these documents, stating your order number, and they will be emailed to you within 4 working days.

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, Ph.D., is the director of Labcompliance and editor of, the global online resource for validation and compliance. He has authored 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 includes seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national healthcare agencies.

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