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Showing posts with the label QA/QC personnel

Produce Safety: The Enigma of a Healthy Diet (Popeye Would Turn Over in his Grave)

Compliance Key INC  -  Life Science Webinars                                                 Michael Brodsky Michael Brodsky, Keynote Speaker at Compliance Key INC. He has been an Environmental Microbiologist for more than 42 years. He is a Past President of the Ontario Food Protection Association (OFPA), the International Association for Food Protection (IAFP) and AOAC International.   Webinar Id:  LSHCBP002  12:30pm PT | 03:30pm ET  12/12/2017  Duration 60min mins  Overview In the United States, more illnesses have been attributed to leafy vegetables (22%) than to any other commodity: illnesses associated with leafy vegetables are the second most frequent cause of hospitalizations (14%) and the fifth most frequent cause of death (6%). This situation is probably reflected globally. Sho...

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...

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

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...