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TZID:America/New_York
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DTSTART:19700308T020000
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BEGIN:VEVENT
UID:2140535:Event:68977
DTSTAMP:20260519T020751Z
SUMMARY:Webinar on UDI Implementation - What is required ?
DESCRIPTION:Description :\nThe US FDA has published the final regulati
 ons for Unique Device Identification (UDI). Manufacturers must start i
 mplementation planning.\nUDI implementation requires understanding of 
 several major steps:\n                        
        Producing compliant device labels, packaging\n     Â
  Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â  Uploading the approp
 riate information into the GUIDID\n                 Â
  Â Â Â Â Â Â Â Â Â Â Â Â  Updating affected work instructions and/or s
 tandard operating\nThe UDI regulations include changes:\n      Â
  Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â  Part 803 (Medical Devi
 ce Reporting)\n                            
    Part 806 (Medical Devices; Reports of Corrections and Removals)\
 n                               Part 814
  (Pre market Approval of Medical Devices)\n             Â
  Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â  Part 820 (Quality System Regulation)
 \n                               Part 82
 1 (Medical Device Tracking Requirements)\n              
                  Part 822 (Post market Surveillance)\n
 You will learn the UDI elements, the New Requirements and where it sho
 uld be placed (on device, label, labeling and package, and configurati
 ons), and the Global Unique Device Identification Database (GUDID) dat
 a requirements.\nAreas Covered in the Session :\nIntroduction to UDI r
 equirements\nDevice Classifications\nOverview of GUDID key concepts (R
 eview of GUDID Modules)\nThe UDI Record\nUDI on Labels, Labeling and P
 ackaging\nSubmission and 21 CFR 11 requirements\nWho Will Benefit:\nRe
 gulatory Affairs\nQuality Assurance\nLabeling Departments\nQuality Spe
 cialists\nQuality Engineers\n\nFor more information visit https://medt
 echiq.ning.com/events/webinar-on-udi-implementation-what-is-required
DTSTART;TZID=America/New_York:20160420T130000
DTEND;TZID=America/New_York:20160420T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1647
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1647
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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