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UID:2140535:Event:61805
DTSTAMP:20260523T220301Z
SUMMARY:Unique Device Identification (UDI): Upcoming FDA rules, requir
 ements and timelines for industry
DESCRIPTION:This webinar will help you understand and comply to the Un
 ique Device Identification (UDI) policies, both current and the upcomi
 ng FDA requirements for importers, manufacturers and hospitals.\nWhy S
 hould You Attend:\nMedical device industries (manufacturers), hospital
 s and providers should plan proactively to prepare systems and process
 es in order to meet the upcoming UDI requirements and rules. It is cri
 tical to get informed on all these guidances for different stakeholder
 s in order to understand better the increasing complexity of the devic
 e regulatory process (premarket, postmarket).\nThis webinar will provi
 de the current and expected policies for Unique Device Identification 
 (UDI) in US regulated by FDA. We will explain the current guidances (F
 ood and Drug Administration Amendments Act of 2007, proposed rules and
  amendments in 2012), update on upcoming UDI rules and discuss what in
 dustry and hospitals should know to conform to UDI rules. This course 
 will explain the requirements for all these roles in industry that nee
 d conformance to the regulations and the standard process. The FDA (IS
 O) codes and standards for UDI data and processes will be described in
  details at this webinar.\nWe will also explore relevant UDI and stand
 ards in US and we will present the proposed regulations and cases in t
 he field. We will analyze a recent report that FDA published on streng
 thening the medical device post-market surveillance and UDI plans that
  will affect the industry in the coming years. Finally we will expand 
 on current similar UDI initiatives and effort at EU and globally and t
 he role of Global Harmonization Task Force (International Medical Devi
 ce Regulators Forum currently).\nAreas Covered in the Webinar:\n\nOver
 view and timeline of UDI\nProposed UDI regulation(FDA, 2012)\nAmendmen
 t to the UDI Proposed Rule(2012)\nUDI codes and standards\nProposed da
 tes for UDI regulations in US\nBenefits of UDI (supply chain, healthca
 re, industry, public health)\nPost-Market Surveillance & Compliance wi
 th UDI\nLawmakers doubt the release of UDI rule by deadline (2013)\nUD
 I efforts and recommendations in EU and globally\nGlobal Harmonization
  Task Force & International Medical Device Regulators Forum\nFuture Of
  Medical Devices pre- and post-market lifecycle.\n\n\nFor more informa
 tion visit https://medtechiq.ning.com/events/unique-device-identificat
 ion-udi-upcoming-fda-rules-requirements
DTSTART;TZID=America/New_York:20130801T100000
DTEND;TZID=America/New_York:20130801T113000
CATEGORIES:medical, device, webinar
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=703039?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=703039?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=Referral:https://medtechiq.ning.com/profile/Referral
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006570?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
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