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UID:2140535:Event:469727
DTSTAMP:20260601T044212Z
SUMMARY:How to Implement the FDA SUPAC Guidance
DESCRIPTION:This webinar training will cover various topics on Scale-U
 p and Post-Approval Changes (SUPAC). Participants will learn how to pr
 operly scale-up or scale-down pharmaceutical batch process and learn t
 he standard set of documentation to successfully support post-approval
  changes.\nWhy Should You Attend:\nThis webinar will provide an excell
 ent insight into the practical aspects of the process scale-up and wil
 l be an invaluable source of information on batch enlargement and tech
 nology transfer techniques and regulatory requirements. Participants w
 ill learn about regulatory FDA and EU guidelines regarding scale-up an
 d post-approval changes.\n\nLearning Objectives:\n\nBasic scale-up sci
 ence\nRegulatory impact of change control of approved drug manufacturi
 ng process\nHow to properly scale-up or scale-down your pharmaceutical
  batch process\nStandard set of documentation to successfully support 
 post-approval changes\nManaging the technology transfer process\n\n\nA
 reas Covered in the Webinar:\n\nSUPAC IR: Immediate Release Q&A with E
 xamples\nSUPAC MR: Modified Release Q&A with Examples\nSUPAC: Manufact
 uring Equipment Addendum Q&A with Examples\nRisk Based CMC Regulatory 
 Oversight of Post-Approval Change\nWhat kind of documentation do you n
 eed when scaling up your process to comply with the FDA SUPAC Guidance
 ?\nWhat kind of documentation do you need to comply with the FDA SUPAC
  Guidance when moving your approved process to different equipment?\n\
 n\nWho Will Benefit:\n\nFormulators\nProcess engineers\nValidation spe
 cialists\nQuality assurance personnel\nProduction managers occupied wi
 th process and product scale-up and changes in any FDA approved produc
 tion\nAnyone involved in technology transfer and product globalization
 \n\n\nFor more information visit https://medtechiq.ning.com/events/how
 -to-implement-the-fda-supac-guidance
DTSTART;TZID=America/New_York:20211118T100000
DTEND;TZID=America/New_York:20211118T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/how-to-implement-the-fda-supa
 c-guidance-webinar-training-704312-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/how-to-implement-the-fda-supac-gu
 idance-webinar-training-704312-prdw?channel=MedTech%20I.Q
CONTACT:
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9640220900?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
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