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DTSTART:19700308T020000
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UID:2140535:Event:63210
DTSTAMP:20260522T070423Z
SUMMARY:Archiving Clinical Trial Documents - Understanding Regulatory 
 Requirements for Paper and Electronic Records
DESCRIPTION:This webinar will cover regulatory requirements for archiv
 ing clinical trial documents, both paper and electronic records. It wi
 ll focus on the key components of a digital preservation strategy to e
 nsure the ongoing retrievability and accessibility of clinical trial e
 lectronic records.\n\nWhy Should You Attend:\n\nDo you understand what
  regulatory inspectors understand an archive to consist of?\nDo you un
 derstand what controls need to be in place for trial documents to be c
 onsidered to be “archived”?\nDo you understand how to guarantee re
 trievability and accessibility of electronic documents long after the 
 software that created them exists and for as long as those records are
  retained?\n\nIf you do not know the answer to one or more of these qu
 estions attending this one-hour webinar will help you to be better inf
 ormed requirements for archiving.\nThis session will be introduced wit
 h an overview of the regulations that pertain to archiving of trial do
 cuments, including getting clarification on some of the key terminolog
 y used. We will then explore specific aspects of establishing and mana
 ging archives and how we can effectively meet the expectations of regu
 latory agencies. Managing electronic documents introduces an additiona
 l level of complexity due to the potential obsolescence of hardware, s
 oftware and operating systems and the natural degradation of electroni
 c storage media. We will look at strategies for mitigating these issue
 s.\nLearning Objectives:\nAt the end of this webinar, participants wil
 l understand what the regulatory requirements are for archives and arc
 hival processes and will be able to describe the key components of a d
 igital preservation strategy to ensure the ongoing retrievability and 
 accessibility of electronic records.\nAreas Covered in the Webinar:\n\
 nDefining an archive, an archivist and archive processes\nDetermining 
 appropriate retention times\nRegulatory expectations for archives\nSec
 urity and access control\nPreservation of records\nElectronic archivin
 g\nDigital preservation strategy\n\nWho will Benefit:\nThis webinar wi
 ll provide valuable assistance to the following personnel:\n\nClinical
  IT Project Managers\nClinical Operations Management\nClinical Project
  Managers\nTMF Specialists\nRecords Managers\nArchivist\nClinical Comp
 liance Officers\n\nInstructor Profile:\nEldin Rammell, is an independ
 ent records management consultant with over 25 years experience within
  the life sciences sector. Gaining experience within major pharmaceuti
 cal companies, he has managed on site and off site records centres and
  archives and overseen major records management projects. During the l
 ast 10 years, he has been the owner and principal consultant at Rammel
 l Consuting Ltd, providing bespoke consultancy in clinical records man
 agement. He has been engaged as a consultant on several eTMF implement
 ation projects for clients ranging from multinational pharmaceutical c
 ompanies to small biotechnology companies. He is recognized as an indu
 stry key opinion leader in the area of TMF management and is a regular
  conference speaker.\n\nFor more information visit https://medtechiq.n
 ing.com/events/archiving-clinical-trial-documents-understanding-regula
 tory
DTSTART;TZID=America/New_York:20140225T100000
DTEND;TZID=America/New_York:20140225T110000
CATEGORIES:clinical
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=703265?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=703265?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER:ComplianceOnline
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 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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