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35118 Conferences

QSR Device Inspections – Transition from “Barely Surviving” to “Gaining Control”

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-10-27
Last Date Last Day: 2010-10-27

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This Medical Device Quality System training will discuss how to Create an adequate quality system that meets FDA’s requirements and Effectively prepare for upcoming Quality System Regulation (QSR) inspections.

Why Should You Attend:

Your newly approved device is now on the market and is undergoing mass production at your manufacturing facility. What’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 FDA’s expectation before the inspection occurs is a critical step to transitioning from “barely surviving” to “gaining control”.

Who Will Benefit:

This webinar will provide valuable information to personnel in Medical Device Manufacturers including:

* R&D managers
* QA managers/staff
* Management representatives
* Members of multi-discipline design teams
* Product, project, program managers
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