Compliance Key - Compliance Online Training Webinars, Regulatory, Medical Device, FDA, Financia

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...

Compliance Key INC -  FDA Compliance 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.   Webinar Id:  LSHCMEW004  10:00 AM PT | 01:00 PM ET  10/24/2017  Duration 60 mins  Overview This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA requirem...