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DTSTART:19700308T020000
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UID:2140535:Event:66025
DTSTAMP:20260411T114736Z
SUMMARY:Webinar On Transfer of Analytical Methods and Procedures accor
 ding to USP 1224
DESCRIPTION:Description :\nWhen validated methods are transferred betw
 een laboratories and sites, their validated state should be maintained
  to ensure the same reliable results in the receiving laboratory. For 
 a long time there was no official guidance on what exactly is expected
  to maintain 'the validated state'. Now the USP has published an updat
 ed general chapter <1224>. Also the FDA has released an official guida
 nce on how to conduct and document method transfer. In addition the FD
 A has included requirements for method transfer in its new draft guida
 nce from 2014 on validation of analytical methods. This seminar will g
 ive a good understanding of USP and FDA requirements and provide recom
 mendations and tools for effective implementation.\nAreas Covered in t
 he Session :\nFDA and International expectations for method transfer\n
 Examples of FDA warning letters and how to avoid them\nThe FDA Guidanc
 e on method transfer.\nThe USP chapter <1224>: history, status, future
 \nFour approaches for analytical method transfer and testing\nResponsi
 bilities of the transferring and receiving laboratory\nDeveloping a tr
 ansfer plan and a pre-approval protocol\nConducting comparative studie
 s\nCriteria and approaches for risk based testing: what, when, how muc
 h?\nThe importance and selection of acceptance criteria\nDealing with 
 technology transfer: validation requirements, regulatory notification.
 \nMethod transfer from standard HPLC to UHPLC\nMost likely failures du
 ring method transfer\nHandling deviations from documented acceptance c
 riteria\nCriteria for transfer waiver (omission of formal transfer)\nM
 ethod transfer protocol and summary report\nFor easy implementation, a
 ttendees will receive:\nSOP: Transfer of Analytical Methods\nChecklist
 : Transfer of Analytical Methods and Procedures\nMaster Plan template 
 and examples: - Transfer of Analytical Methods and procedures\nWho Wil
 l Benefit:\nLab Supervisors and Managers\nQA managers and personnel\nA
 nalysts\nResearch & Development in Pharmaceutical industry\nPharmaceut
 ical quality control\nContract laboratories\nCROs\nConsultants\nTeache
 rs\nPrice Tags:\nLive\nSingle Live : For One Participant\n$ 249\nCorpo
 rate Live : For Max. 10 Participants\n$ 899\nRecording\nSingle REC : F
 or One Participant - Unlimited Access for 6 Months\n$ 299\nFor more in
 formation and enquiries contact us at\nCompliance Trainings\n5939 Cand
 lebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #41
 6-915-4458  Email : support@compliancetrainings.com\nFor more inform
 ation about this event please visit\nhttps://compliancetrainings.com/S
 iteEngine/ProductDetailView.aspx?id=FDB1453\nLike Us ON Facebook:\nhtt
 ps://www.facebook.com/events/862004993871327/\n\nFor more information 
 visit https://medtechiq.ning.com/events/webinar-on-transfer-of-analyti
 cal-methods-and-procedures
DTSTART;TZID=America/New_York:20150416T180000
DTEND;TZID=America/New_York:20150416T190000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1453
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1453
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562013087?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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