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FDA requires that all software in computer systems used in GxP activities be validated. The validation of computer system software is completely different from that of device software (embedded software). Verification is much more than testing. It is testing plus design control and configuration management.
How to plan and conduct a risk-based validation will be explained. The overall risk for a 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. The 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.
The validation of computer system software is entirely different from that of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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