Unique Device Identification (UDI): Upcoming FDA Rules, Requirements and Timelines for Industry and Hospitals

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					GlobalCompliancePanel                                               Your Gateway to Regulatory Compliance

Live Webinar on

Unique Device Identification (UDI): Upcoming FDA Rules,
Requirements and Timelines for Industry and Hospitals

Date: Wednesday, July 17, 2013                                     Time: 10:00 AM PDT | 01:00 PM EDT

   Duration:    90 Minutes
   Location:    Online                                                            Register Now
 Instructor:    Kosta Makrodimitris

Overview:
US-FDA has released a proposed rule (2012) that most medical devices distributed in the United
States carry a unique device identifier (UDI). Congress passed legislation in 2007(FDAAA) directing
the FDA to develop regulations establishing a UDI system for medical devices.


Areas covered in the session:

    l   Overview and timeline of UDI
    l   Proposed UDI regulation(FDA, 2012)
    l   Amendment to the UDI Proposed Rule(2012)
    l   UDI codes and standards
    l   Proposed dates for UDI regulations in US
    l   Benefits of UDI (supply chain, healthcare, industry, public health)
    l   Post-Market Surveillance & Compliance with UDI
    l   Lawmakers doubt the release of UDI rule by deadline(2013)
    l   UDI efforts and recommendations in EU and globally
    l   Global Harmonization Task Force & International Medical Device Regulators Forum
    l   Future Of Medical Devices pre- and post- market lifecycle



Who Will Benefit:                                                    About Speaker

                                                                     Kosta Makrodimitris
    l   Medical Compliance Officers
                                                                     Health IMS Consultant, K Makrodimitris
    l   Health Information Managers
    l   Legal Counsel, Regulatory affairs                            Kosta Makrodimitris, PhD, CF-FDA,
    l   Data and Device Standards experts                            C P-EHR, is Biomedical/Health
    l   Health care distributors                                     Informatics Advisor, Author &
                                                                     Strategist.
    l   Hospitals and health care providers
    l   Health care industry professionals                           Dr. Makrodimitris is the principal for K
    l   Healthcare & Devices CIO/CFO/CTO                             Makrodimitris that specializes in Health
                                                                     IT & BIO business development,
    l   Audit/Inspection coordinators, internal auditors
                                                                     eHealth education, Health Information
    l   QA / QC managers, executives and personnel                   policy.
    l   Health IT / IS managers and personnel
    l   Entrepreneurs (Devices, Surveillance, Informatics)           He is certified on EHR/PHR, Clinical

    l   Consultants and Strategists
                                                                     Trials,   ...more



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