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UID:2140535:Event:468533
DTSTAMP:20260411T213244Z
SUMMARY:Change Control Best Practices - Avoiding Unintended Consequenc
 es of Changes
DESCRIPTION:One of the top 10 FDA 483 and Warning Letter citations is 
 for inadequate change control. Change control receives detailed scruti
 ny during FDA inspections, and FDA reviews change control documentatio
 n to determine that changes did not adversely impact products, process
 es, equipment, facilities, etc. A single inadequate change may lead to
  significant negative events, including release of sub-standard produc
 t or product recall. A pattern of inadequate changes may require costl
 y and time-consuming system remediation efforts.\nIt is therefore crit
 ically important to assure that changes are properly described, justif
 ied, assessed for risk, implemented, and documented. Changes must also
  be prospectively reviewed by appropriate subject matter experts. Furt
 hermore, certain major changes (e.g. manufacturing, specifications) ma
 y require regulatory filings and/or prior regulatory approval.\nThis s
 eminar will help all personnel involved in proposing, assessing, and i
 mplementing changes to understand and successfully apply Change Contro
 l best practices. Key focus will be placed on change proposals, justif
 ication / risk assessment and change execution / implementation. The i
 mportance of proper planning, critical thinking skills, and co-ordinat
 ion of all change activities will also be discussed. Techniques for as
 suring robust Change Control programs in light of COVID-19 restriction
 s will also be discussed.\nThis is a practical how-to course, designed
  to provide participants with skills they can immediately apply to cha
 nge controls within their own organizations. Case studies will allow p
 articipants to practice skill sets in cooperation with the instructor.
 \nLearning Objectives:\nUpon completing this course, participants shou
 ld be able to:\n\nUnderstand the purpose of change control\nUnderstand
  regulatory requirements and FDA expectations for change control\nIden
 tify what types of changes are /are not subject to change control\nPro
 perly describe changes\nProperly justify changes\nDevelop a comprehens
 ive Change Execution Plan\nConduct a proper change Risk Assessment\nEn
 sure proper execution of changes\nEnsure proper implementation of chan
 ges\nDevelop a complete Change Control documentation package\nUtilize 
 critical thinking skills throughout the change control process\nAvoid 
 pitfalls during the change control process\n\nWho will Benefit:\nThis 
 course is designed for people tasked with:\n\nAuthoring change proposa
 ls\nAssessing / approving change proposals\nExecuting / implementing c
 hanges\n\nThe following personnel will benefit from the course:\n\nCha
 nge proposal authors\nReviewers / approvers of change controls\nChange
  control system owners\nProduction staff / management\nEngineering sta
 ff / management\nValidation staff /management\nQC staff / management\n
 \n\nFor more information visit https://medtechiq.ning.com/events/chang
 e-control-best-practices-avoiding-unintended-consequences-1
DTSTART;TZID=America/New_York:20210518T073000
DTEND;TZID=America/New_York:20210519T133000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-change-control-expectatio
 ns-best-practices-seminar-training-80244SEM-prdsm?channel=MedTech%20I.
 Q
URL:https://www.complianceonline.com/fda-change-control-expectations-b
 est-practices-seminar-training-80244SEM-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/8719133894?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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