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DTSTART:19700308T020000
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UID:2140535:Event:70054
DTSTAMP:20260918T091009Z
SUMMARY:Webinar on Raw Materials Risk Management in cGMP Facilities
DESCRIPTION:This webinar will address the procedures, provide and disc
 uss suggested templates, necessary to develop or modify and then use t
 he ISO 14971 and Q9 models to perform and document such activities for
  any medical product, and satisfy U.S. FDA cGMP and CE-marking / Notif
 ied Body expectations. It will examine the additional actions necessar
 y to make it a useful product reference, CAPA, root cause / failure in
 vestigation, and validation prioritization, and training tool, and how
  to maintain it as a “living document”.\n \nAreas Covered in the 
 Session :\nThe Revised ISO 14971 for Devices (with ALARP discussion)\n
 ICH Q9 for Pharma\nProduct Hazard Analysis\nFault Tree Analysis\nDesig
 n, Process, and Use[r] Failure Mode, Effects and Criticality Analysis\
 nSuggested Risk Management File / Report, FMECA, FTA Templates\nDrivin
 g Product Risk Management down to RM and Component Levels\nWhy and How
  to use the ISO 14971 \"Model\" in all Regulated Industries\nThe Team 
 and Its Involvement – Who, When and How\nUsing the Completed Documen
 t – It’s Real Value “In the Loop”\nWho Will Benefit:\nThis web
 inar will provide valuable assistance to all U. S. FDA-regulated compa
 nies. It will assist in their developing / reviewing / modifying their
  product design / formulations, manufacturing processes, and use envir
 onment in light of product risk to the end user. Also in addressing th
 eir regulatory compliance stance in view of the areas the FDA indicate
 s are of growing / future interest / emphasis. Its principles apply to
  personnel / companies in the Medical Devices, Pharmaceutical, Diagnos
 tic, Biologics and Combination products fields. The employees who will
  benefit include:\nSenior management\nMiddle management\nResearch and 
 Development\nEngineering\nSoftware\nQA / RA\nManufacturing\nOperators\
 nConsultants\ncGMP instructors\nAll personnel involved in verification
  and/or validation planning, execution and documentation. \n\nFor mor
 e information visit https://medtechiq.ning.com/events/webinar-on-raw-m
 aterials-risk-management-in-cgmp-facilities
DTSTART;TZID=America/New_York:20160615T130000
DTEND;TZID=America/New_York:20160615T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1845
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1845
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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