This event ended on September 19, 2018 4:30 AM EDT

Webinar On "Computer System Validation"

Wednesday Sep 19, 2018 from 03:30 to 04:30 (UTC -04:00)


Wednesday Sep 19, 2018 from 03:30 to 04:30 (UTC -04:00)


Description : FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.

How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. You’ll learn how to integrate risk based supplier evaluation into the validation process.

Validation Master plan and System Validation Plans will be explained

Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for each level of complexity and risk will be described.

Areas Covered in the Session :

  • Validation strategy
  • Requirements documentation
  • Complexity and risk analysis
  • Creating a detailed test plan based on risk
  • Supplier qualification
  • IQ, OQ and PQ
  • Who Will Benefit:
    • Computer system developers
    • Systems development engineers
    • QA/ QC
    • Lab Managers and Analysts
    • Production Managers
    • Engineering managers

    About Speaker: 

     Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.

    Edwin Waldbusser has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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