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browse by categories     Audio Conference Archive     Audio Conferences     Past Conference Documentation     Webinar Archive     Webinars     Workshops product FDA Reports of Corrections and Removals for Medical Devices This product was added to our catalog on Tuesday 14 July, 2009. Item #: Price:  $395.00    Product description 60 Minute Webinar Recording Speaker Casper E. Uldriks, JD, MDiv. Associate Center Director Regulatory Guidance and Government Affairs Center for Devices and Radiological Health FDA The Reports of Corrections and Removals (C&R) regulation is concerned about what firms do about problems identified through Medical Device Report (MDR) regulation and the Quality System Regulation (QSR). These regulations create a foundation for risk management that is central to FDA’s regulatory concerns, particularly for C&R. The seminar will include the following postmarket regulatory issues: Purpose of the regulation Parallel concepts with MDR and voluntary recalls concerning risk to health Key sections of the C&R regulation Enforcement C&R as part of a interdependent regulatory system for devices The session summarizes the same information that has been used to train FDA investigators. Cost The cost to purchase the video recording is $395. Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.

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