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UID:2140535:Event:66233
DTSTAMP:20260520T151815Z
SUMMARY:Webinar On Laboratory Developed Tests
DESCRIPTION:Description : \nThe webinar clarifies the regulatory conc
 ern that FDA has and whether subjecting Laboratory Developed Tests (LD
 Ts) to FDA's device Quality System Regulation can make a measurable di
 fference in the safety and effectiveness (reliability) of special IVDs
 . The arguments on both sides of the issue will be identified and how 
 regulation may adversely impact the quality of health care we have tod
 ay. The presumption by FDA is that regulation will improve these speci
 al IVDs and, thereby, improve the quality of health care.\nYou will le
 arn how reporting regulations, such as FDA's manufacturing regulations
  (Quality System Regulation (21 CFR Part 820)), Medical Device Reporti
 ng (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR P
 art 806) would apply to LDTs. Once you identified the regulatory oblig
 ations, the logistical issues will be discussed and the types of game 
 plans that may be necessary.\nAreas Covered in the Session :\nReasons 
 for FDA regulation\nApplicable regulations\nUse and availability of LD
 Ts\nIdentify logistical risks\nSteps for implementation\nInteractive Q
 &A Session\n \nWho Will Benefit:\nA must attend webinar for:\nClinica
 l laboratories\nPathology practice groups\nMedical institutions (hospi
 tals) using Laboratory Developed Tests\nPractitioners\nHealthcare main
 tenance organizations\nMedical device and diagnostic manufactures\nRis
 k managers for healthcare practices\nRegulatory affairs managers for I
 VD manufacturers\nCost control consultants for healthcare practices\nP
 rice tags:\nLive\nSingle Live : For One Participant\n$ 249\nCorporate 
 Live : For Max. 10 Participants\n$ 899\nRecording\nSingle REC : For On
 e Participant - Unlimited Access for 6 Months\n$ 299\nFor more informa
 tion and enquiries contact us at\nCompliance Trainings\n5939 Candlebro
 ok Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915
 -4458  Email : support@compliancetrainings.com\nFor more information
  about this event please visit\nhttps://compliancetrainings.com/SiteEn
 gine/ProductDetailView.aspx?id=FDB1552\n\nFor more information visit h
 ttps://medtechiq.ning.com/events/webinar-on-laboratory-developed-tests
DTSTART;TZID=America/New_York:20150615T130000
DTEND;TZID=America/New_York:20150615T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1552
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1552
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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