VIEWS: 18 PAGES: 1 CATEGORY: Healthcare Management POSTED ON: 3/12/2013
This webinar will greatly help device industry and relevant professionals understand how to define, document, implement, and maintain the procedures for MDR.
GlobalCompliancePanel Your Gateway to Regulatory Compliance Live Webinar on FDA-Compliant Medical Device Reporting (MDR) Date: Thursday, April 25, 2013 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes Location: Online Register Now Instructor: David Lim Overview: This webinar is intended to demonstrate how to define, document, implement, and maintain the necessary procedures for medical device reporting. In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. Areas covered in the session: l Relevant Statutes and FDA Regulations l Definitions l Regulatory Requirements for Medical Device Reporting (MDR) l Requirements to Be Addressed in the Procedures l How to Fill Out MDR Forms l How and Where to Report Medical Device Adverse Events l Reporting Requirements for the User Facilities, Manufacturers, and Importers l Enforcements: Numerous Case Studies Who Will Benefit: About Speaker David Lim l Complaint Handling, Risk Chairman and CEO, Regulatory Doctor Management Managers and David Lim obtained his Ph.D. in biological sciences at Directors the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” l Compliance Officers and Legal Since then, Dr. Lim has held various positions at Duke, Counsel US National Laboratories, Intrexon Corporation, l Regulatory Affairs Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., l Clinical Affairs A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public l Quality Assurance, Quality Control, Meeting. Prior to founding his own consulting firm and Quality Systems (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice l Research and Development President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein l Product and Development Dr. Lim provided inspiring and actionable solutions for l Marketing sustainable business operation. Dr. Lim as Regulatory l Site Managers and Consultants. Doctor provides practical, actionable and strategic l Contract Manufacturing solutions integrated with emotional intelligence ...more Organization l Contract Research Organization l Senior and Executive Management l Contractors and Subcontractors. Click here to register for this webinar Suggest a Topic More Webinars 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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