Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products.
Toll Free Number: 800-447-9407 Live Webinar on Managing Your Medical Device Reporting (MDR)Program for Compliance Success Date: Wednesday, March 13, 2013 Time: 10:00 AM PST | 01:00 PM EST Course "Managing Your Medical Device Reporting (MDR)Program for Compliance Success" has been Duration: 90 Minutes pre-approved by RAPS as eligible for up to 1.5 Instructor: David R. Dills credits towards a participant's RAC recertification Location: Online upon full completion. David R. Dills Industry Regulatory & Register Now Compliance Consultant, David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape. ...more Overview: Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. Areas covered in the session: l What form should I use to submit reports of individual adverse events and where do I obtain these forms? l How will I know if I require more information about my medical device report? l Reporting device-related deaths and serious injuries and when these are not treated as a product complaint l Understand the manufacturer's reporting requirements and expectations l Are there exemptions, variances, or alternative forms of adverse event reporting requirements? l Learn what constitutes a MDR and how to facilitate this for compliance success l Develop, maintain, and implement written MDR procedures and achieve compliance l Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that the agency deems no longer necessary Who Will Benefit: l All levels of Management Suggest a Topic for all departments and those who desire a better More Webinars understanding or a "refresh" overview l QA/QC l Regulatory Affairs and Compliance Click here to l Engineering/Technical register for this Services/Operations webinar l Consultants It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 43337 Livermore Common, Fremont, CA 94539, USA Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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