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FDA-Compliant Medical Device Reporting (MDR) - Webinar By GlobalCompliancePanel
Website http://bit.ly/10jPzWa |
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Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA
Deadline: April 25, 2013 | Date: April 25, 2013
Venue/Country: California, U.S.A
Updated: 2013-04-08 17:43:20 (GMT+9)
Call For Papers - CFP
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. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. It is critical to understand how to define, document, implement, and maintain the procedures for MDR. This webinar will greatly help device industry and relevant professionals understand how to define, document, implement, and maintain the procedures for MDR. Why Should You Attend: IDevice manufacturers are required to establish and maintain a medical device adverse event reporting system, commonly known as Medical Device Reporting. This webinar will demonstrate how to define, document, implement, and maintain the necessary procedures for medical device reporting. Areas Covered in the Session:Relevant Statutes and FDA RegulationsDefinitionsRegulatory Requirements for Medical Device Reporting (MDR)Requirements to Be Addressed in the ProceduresHow to Fill Out MDR FormsHow and Where to Report Medical Device Adverse EventsReporting Requirements for the User Facilities, Manufacturers, and ImportersEnforcements: Numerous Case StudiesWho Will Benefit:Complaint Handling, Risk Management Managers and DirectorsCompliance Officers and Legal CounselRegulatory AffairsClinical AffairsQuality Assurance, Quality Control, and Quality SystemsResearch and DevelopmentProduct and DevelopmentMarketingSite Managers and Consultants.Contract Manufacturing OrganizationContract Research OrganizationSenior and Executive ManagementContractors and Subcontractors.Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company.Price: $225.00GlobalCompliancePanel NetZealous LLC,161 Mission Falls Lane,Suite 216, Fremont, CA 94539, USAUSA Phone:800-447-9407Fax: 302-288-6884webinars
globalcompliancepanel.com http://www.globalcompliancepanel.com
http://bit.ly/10jPzWaKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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