QSR Device Inspections â€“ Transition from â€œBarely Survivingâ€ to â€œGaining Controlâ€ -- Compli (Medical DeviceTraini)
Venue: Online Event
|Event Date/Time: Nov 23, 2010||End Date/Time: Nov 23, 2010|
Why Should You Attend:
Your newly approved device is now on the market and is undergoing mass production at your manufacturing facility. Whatâ€™s next? Now, you as device manufacturer are subject to an additional set of FDA requirements known as Quality System Regulations (QSR) and FDA can schedule an inspection at any time. Quality System inspections, to the unprepared, can be seen as an overwhelming and intimidating experience; however, understanding the overall purpose of a Quality System and establishing a quality system that will meets FDAâ€™s expectation before the inspection occurs is a critical step to transitioning from â€œbarely survivingâ€ to â€œgaining controlâ€.
The 1st hour of this webinar will introduce and provide an overview of the quality system regulation and FDA requirements expected of device manufacturers. The 2nd hour of this webinar will provide an overview of Quality System Inspections and cover techniques used by FDA Investigators that will help start-up, small and midsize device manufacturers effectively prepare for upcoming Quality System inspections.