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TZID:America/New_York
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DTSTART:19700308T020000
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BEGIN:VEVENT
UID:2140535:Event:68303
DTSTAMP:20260523T221933Z
SUMMARY:Webinar on Clinical IT Inspection Readiness
DESCRIPTION:Description :\nAll Regulatory Agencies are entitled to com
 e in to any company involved in clinical trials and review documentati
 on supporting procedures and computerized systems, in as part of an In
 spection. The most common regulations that will form the back-ground t
 o an inspection with regards to Clinical Trials, are those released by
  ICH and FDA. The aspects of a company that need attention in the run 
 up to an inspection are the documentation related to people and their 
 roles, responsibilities and training; procedures their current version
 s, approval signatories and related dates and computerized systems uti
 lized within the trial processes, and all the documentation that suppo
 rts their validated state.\nThis course provides an understanding of t
 he various activities that need to be completed in preparation for a R
 egulatory Inspection targeting one of the computerized systems that we
 re utilized during a clinical trial. It is vital to prepare adequately
  for a regulatory inspection to limit the findings documented by the i
 nspectors.\nAreas Covered in the Session :\nWhat happens during an ins
 pection?\nThe component parts of an IT system\nRegulatory Inspection e
 xpectations and examples of findings\nOverview of Computer System Vali
 dation\nGood Document Practice including archiving\nInspection prepara
 tion\nInspection behaviours\nWho Will Benefit:\nQuality Assurance Team
 s\nTrial Management Teams\nData management Teams\nClinical Research As
 sociates\nProject Managers\nIT staff who may be called upon as System 
 Owners or Programmers\nClinical Trial Data Trainers\nClinical Trial Da
 ta Managers\nDocumentation Teams\nFor more information and enquiries c
 ontact us at\nCompliance Trainings\n5939 Candlebrook Ct, Mississauga,
  ON L5V 2V5, Canada  Customer Support : #416-915-4458  Email : sup
 port@compliancetrainings.com\nFor more information about this event pl
 ease visit\nhttps://compliancetrainings.com/SiteEngine/ProductDetailVi
 ew.aspx?id=FDB1850\n\nFor more information visit https://medtechiq.nin
 g.com/events/webinar-on-clinical-it-inspection-readiness
DTSTART;TZID=America/New_York:20160212T130000
DTEND;TZID=America/New_York:20160212T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1850
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1850
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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