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FDA-Compliant Medical Device Reporting (MDR) - Webinar By GlobalCompliancePanel

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FDA-Compliant Medical Device Reporting (MDR) - Webinar By GlobalCompliancePanel Powered By Docstoc
					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.




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DOCUMENT INFO
Description: This webinar will greatly help device industry and relevant professionals understand how to define, document, implement, and maintain the procedures for MDR.