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Software Validation Program That will Satisfy FDA Requirements – 2017
June 8 @ 10:00 am - 11:00 am$150.00
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.
Why should you Attend:
Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries.
Areas Covered in the Session:
Software validation more than testing
Unit,integration and system testing
Challenges to the software
Who Will Benefit:
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.
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