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Showing posts with the label Engineering Management

Conducting a Software Validation of Medical Device to Meet FDA Requirements

Compliance Key INC -  Medical Device Training                                           Edwin Waldbusser Ed is Keynote Speaker at Compliance key Inc . He is retired from industry after 30 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.   Webinar Id:  LSHCMEW007  10.00 AM PT | 01.00 PM ET  12/04/2017   Duration 90 mins  Overview This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysi...