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DESCRIPTION:Use coupon COMPLIANCE15 to get 15% discount on this virtual se
 minar\n\nOne of the top 10 FDA 483 and Warning Letter citations is for in
 adequate change control. Change control receives detailed scrutiny during
  FDA inspections\, and FDA reviews change control documentation to determ
 ine that changes did not adversely impact products\, processes\, equipmen
 t\, facilities\, etc. A single inadequate change may lead to significant 
 negative events\, including release of sub-standard product or product re
 call. A pattern of inadequate changes may require costly and time-consumi
 ng system remediation efforts.\n\nIt is therefore critically important to
  assure that changes are properly described\, justified\, assessed for ri
 sk\, implemented\, and documented. Changes must also be prospectively rev
 iewed by appropriate subject matter experts. Furthermore\, certain major 
 changes (e.g. manufacturing\, specifications) may require regulatory fili
 ngs and/or prior regulatory approval.\n\nThis seminar will help all perso
 nnel involved in proposing\, assessing\, and implementing changes to unde
 rstand and successfully apply Change Control best practices. Key focus wi
 ll be placed on change proposals\, justification / risk assessment and ch
 ange execution / implementation. The importance of proper planning\, crit
 ical thinking skills\, and co-ordination of all change activities will al
 so be discussed. Techniques for assuring robust Change Control programs i
 n light of COVID-19 restrictions will also be discussed.\n\nThis is a pra
 ctical how-to course\, designed to provide participants with skills they 
 can immediately apply to change controls within their own organizations. 
 Case studies will allow participants to practice skill sets in cooperatio
 n with the instructor.\n\nLearning Objectives:\nUpon completing this cour
 se\, participants should be able to:\n\n\nUnderstand the purpose of chang
 e control\nUnderstand regulatory requirements and FDA expectations for ch
 ange control\nIdentify what types of changes are /are not subject to chan
 ge control\nProperly describe changes\nProperly justify changes\nDevelop 
 a comprehensive Change Execution Plan\nConduct a proper change Risk Asses
 sment\nEnsure proper execution of changes\nEnsure proper implementation o
 f changes\nDevelop a complete Change Control documentation package\nUtili
 ze critical thinking skills throughout the change control process\nAvoid 
 pitfalls during the change control process\n\nWho will Benefit:\nThis cou
 rse is designed for people tasked with:\n\n\nAuthoring change proposals\n
 Assessing / approving change proposals\nExecuting / implementing changes\
 n\nThe following personnel will benefit from the course:\n\n\nChange prop
 osal authors\nReviewers / approvers of change controls\nChange control sy
 stem owners\nProduction staff / management\nEngineering staff / managemen
 t\nValidation staff /management\nQC staff / management\nRegulatory Affair
 s staff / management\nQA staff / management\n\nThis course is designed fr
 om a pharmaceutical manufacturing perspective\; however\, since the main 
 focus is on techniques and practices\, the course material may be equally
  applied to biologics and medical device environments. Please note that t
 his seminar focuses on changes to equipment\, facilities\, materials/comp
 onents\, test methods\, suppliers\, specifications\, etc. Document Change
  Control is discussed as a supporting element\; however\, it is not the m
 ain focus.\n
DTEND:20260324T140000
DTSTAMP:20260417T101148Z
DTSTART:20260323T080000
LOCATION:\,
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SUMMARY:Use coupon COMPLIANCE15 to get 15% discount on this virtual semina
 r\nOne of the top 10 FDA 483 and Warning Letter citations is for inadequa
 te chang...
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