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DTSTART:19700308T020000
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UID:2140535:Event:471950
DTSTAMP:20260411T215831Z
SUMMARY:Reviewing Drug Product Batch Records
DESCRIPTION:Batch record review is an important step in the release of
  a medicinal product. This webinar sets out the regulatory requirement
 s for batch records and sets out a systematic approach for review. Tre
 nding of batch data is also discussed.\n\nWhy Should You Attend:\nBatc
 h record review is a GMP requirement. Furthermore, trending of manufac
 turing data facilitates continuous product improvement, which is the f
 ocus of a pending ICH guidance document (ICH Q12). Pharmaceutical manu
 facturers will be expected to demonstrate that their manufacturing pro
 cesses continue to produce medicinal products of a consistently high q
 uality.\nBatch records can also be used to identify sources of manufac
 turing variability, enabling improvements to be made to the production
  method. This webinar details current regulatory expectations and sets
  out a logical approach for batch record review. Methods for trending 
 batch data will also be discussed. In addition to understanding regula
 tory expectations, you will learn how to use batch records as tools to
  facilitate continuous improvement.\nAreas Covered in the Webinar:\n\n
 Regulatory requirements for batch review (EU and US)\nImportant areas 
 to check in batch records\nCommon errors\nExamples of deficiencies lea
 ding to regulatory enforcement action\nOverview of the draft ICH Q12 g
 uidance\nICH Q12 and Quality by Design\nBenefits of continuous improve
 ment\nApproaches to data trending\n\nWho Will Benefit:\n\nProduction s
 taff\nProduction management\nQuality assurance professionals\nQualifie
 d persons (EU)\nRegulatory affairs professionals\n\n\nFor more informa
 tion visit https://medtechiq.ning.com/events/reviewing-drug-product-ba
 tch-records
DTSTART;TZID=America/New_York:20220318T100000
DTEND;TZID=America/New_York:20220318T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/reviewing-drug-product-batch-
 records-webinar-training-706287-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/reviewing-drug-product-batch-reco
 rds-webinar-training-706287-prdw?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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 /file/get/10206604868?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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