Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
Website https://www.complianceonline.com/complaint-handling-medical-device-reporting-and-recalls-seminar-tra |
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Deadline: May 04, 2020 | Date: May 14, 2020-May 15, 2020
Venue/Country: Minneapolis, MN, U.S.A
Updated: 2020-02-13 21:48:09 (GMT+9)
Call For Papers - CFP
Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.By attending this seminar, you will discover:How to overcome one of the biggest obstacles device manufacturers faceHow the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentationHow and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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