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.
Why should you Attend:
Validation of computer system software is completely different than validation 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.
Areas Covered in the Session:
Complexity and risk analysis
Creating a detailed test plan based on risk
IQ, OQ and PQ
Who Will Benefit:
Computer System Developers
Systems Development Engineers
Lab Managers and Analysts
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 US and internationally 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.
Event Fee: One Dial-in One Attendee Price: US$150.00
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Email: [email protected]