Medical Device Complaints, MDRs, and Reports

May 07 – 08, 2013 — Sheraton Crystal City, Arlington, VA

How do you implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDR's, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Through didactic sessions, interactive exercises, and discussion of pre-submitted questions, expert industry faculty explore these issues in practical terms.

MTLI wants you to know the elements of an effective complaint management system, FDA's expectation about trending complaints from non-US markets, how to ensure that your electronic records database handling complaints complies with 21 CFR Part 11, how to investigate complaints to determine if they are MDR's, the dos and don'ts when informing FDA of a product problem, FDA's involvement in health hazard evaluation and classification, and more...

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