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DTSTART:19700308T020000
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UID:2140535:Event:468702
DTSTAMP:20260411T113909Z
SUMMARY:Validation, Verification and Transfer of Analytical Methods
DESCRIPTION:Analytical methods used for GxP purposes should be validat
 ed to ensure the reliability, consistency and accuracy of analytical d
 ata. Compendial methods should be verified to demonstrate the suitabil
 ity of laboratories to successfully run the method and when methods ar
 e transferred between laboratories successful transfer should be demon
 strated through testing or a transfer waiver, if justified. If a labor
 atory uses an alternative method instead of a compendial method, equiv
 alence or superiority of the alternative method should be demonstrated
 .\nRecent guidance on method validation and transfer has been produced
  by FDA and EMA, and USP has guidance chapters on method validation, v
 erification and transfer, equivalence testing and statistical evaluati
 on. Articles in US Pharmacopeial Forum have introduced the concepts of
  measurement uncertainty and lifecycle management for analytical proce
 dures. Lifecycle management has also been the subject of recent FDA an
 d ICH publications.\nThis 2-day seminar will help attendees to underst
 and regulatory requirements for method validation, verification and tr
 ansfer. It will also suggest ways to de-risk the method validation pro
 cess through prior evaluation of method performance and the use of eff
 ective protocols.\nLearning Objectives:\n\nUnderstand the regulatory r
 equirements for validation of analytical methods\nLearn how to plan, e
 xecute and document development and validation of in-house methods\nBe
  able to explain the different requirements for validation, verificati
 on and transfer of analytical procedures\nUnderstand the principles of
  validation of in-house methods, verification of compendial methods an
 d method transfer\nKnow how to demonstrate equivalence to compendial m
 ethods\nUnderstand the important qualities of stability-indicating met
 hods\nBe able to select test parameters, test conditions and acceptanc
 e criteria for different analytical measurements\nKnow how to plan, ju
 stify and document revalidation after method changes\nUnderstand impor
 tant indicators of the suitability of a method for routine QC use\nUnd
 erstand approaches for the statistical evaluation of validation test r
 esults\nUnderstanding what questions will be asked during audits and i
 nspections and how to answer them\n\nWho will Benefit:\n\nQuality assu
 rance personnel\nQuality control and method development analysts\nVali
 dation specialists\nLaboratory managers and supervisors\nRegulatory af
 fairs personnel\nConsultants\n\n\nFor more information visit https://m
 edtechiq.ning.com/events/validation-verification-and-transfer-of-analy
 tical-methods-1
DTSTART;TZID=America/New_York:20210517T100000
DTEND;TZID=America/New_York:20210518T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/lab-analytical-compendial-met
 hod-ich-q2-glp-part11-annex11-qbd-seminar-training-80291SEM-prdsm?chan
 nel=MedTech%20I.Q
URL:https://www.complianceonline.com/lab-analytical-compendial-method-
 ich-q2-glp-part11-annex11-qbd-seminar-training-80291SEM-prdsm?channel=
 MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/8912506468?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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