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