Managing Your Medical Device Reporting (MDR)Program for Compliance Success - Webinar By GlobalCompliancePanel

							                                                                   Toll Free Number: 800-447-9407


                                                                     RAPS Approved Webinar on


Managing Your Medical Device Reporting (MDR)Program for
Compliance Success

Date: Thursday, November 29, 2012                                    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. On July 31, 1996, the new Medical Device Reporting
(MDR) regulation became effective for user facilities and device manufacturers. The statutory
authority for the MDR regulation is section 519(a) of the FFD&C Act as amended by the Safe Medical
Devices Act (SMDA) of 1990.


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
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1200 Wilmington DE 19801

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