BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:471214
DTSTAMP:20260531T134437Z
SUMMARY:FDA Compliance and Clinical Trial Computer System Validation
DESCRIPTION:Course Description:\nThe FDA governs the computer systems 
 used to collect, analyze, transfer and report data that is in support 
 of human clinical trials required for drug approval. FDA oversight is 
 based on a Predicate Rule, known as \"Good Clinical Practices,\" or si
 mply, \"GCPs.\"\nComputer systems subject to GCP requirements must be 
 thoroughly and appropriately validated in accordance with FDA's guidan
 ce on computer system validation. This involves a rigorous set of phas
 es and steps to ensure that, in the language of FDA, \"a system does w
 hat it purports to do.\"\nThe cost of adequately validating a clinical
  trial computer system can be high, and must be weighed against system
  risk and usage. GAMP 5 system classification guidelines can help ensu
 re that a clinical trial system is categorized appropriately, based on
  the type of system and technology involved. Along with risk, system c
 lassification can provide a clear-cut pathway for validating a system,
  based on the appropriate level of testing and validation effort.\nIn 
 this two day Virtual Seminar you will learn about FDA's expectations 
 for classifying, assessing the risk, testing, and validating a compute
 r system used in clinical trial work. You will learn in detail about t
 he System Development Life Cycle (SDLC) methodology used to approach C
 omputer System Validation (CSV), including all of the phases, sequenci
 ng of events, deliverables, and documentation requirements.\nLearning 
 Objectives:\nUpon completing this course participants should:\n\nUnder
 stand FDA requirements for clinical trial Computer System Validation (
 CSV)\nUnderstand the System Development Life Cycle (SDLC) approach to 
 validation\nUtilize GAMP 5 system classification and risk methodologie
 s for categorizing systems and developing a validation pathway\nUnders
 tand how to build a complete validation strategy and program for clini
 cal trial systems\nKnow how to manage the validation process and creat
 e FDA-compliant documentation\nKnow how to monitor a clinical trial sy
 stem that is in production, governing the data and system through reti
 rement\nUnderstand the roles and responsibilities required to validate
  a clinical trial system\n\nWho Will Benefit:\nThis seminar is intende
 d for those working in the FDA-regulated industries, including pharmac
 eutical, medical device, biological, animal health, organ donation and
  tobacco. Functions that are applicable include research and developme
 nt, clinical sample manufacturing, packaging, labeling and distributio
 n, clinical testing and management, adverse events management and post
 -marketing surveillance.\nYou should attend this seminar if you are re
 sponsible for planning, executing or managing the implementation of an
 y clinical trial system governed by FDA regulations, or if you are mai
 ntaining or supporting such a system. Examples of who will benefit fro
 m this webinar include:\n\nData “Owners”\nData “Stewards”\nInf
 ormation Technology Analysts\nInformation Technology Developers and Te
 sters\nQC/QA Managers and Analysts\nClinical Data Managers and Scienti
 sts\nAnalytical Chemists\nCompliance and Audit Managers\n\n\nFor more 
 information visit https://medtechiq.ning.com/events/fda-compliance-and
 -clinical-trial-computer-system-validation
DTSTART;TZID=America/New_York:20220217T110000
DTEND;TZID=America/New_York:20220218T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-clinical-trial-computer-s
 ystem-validation-gxp-21cfr-part11-seminar-training-80376SEM-prdsm?chan
 nel=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-clinical-trial-computer-syste
 m-validation-gxp-21cfr-part11-seminar-training-80376SEM-prdsm?channel=
 MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9948012073?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR