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DTSTAMP:20260516T062340Z
SUMMARY:Analytical Method Validation and Transfer
DESCRIPTION:This course will provide a thorough review of regulatory g
 uidelines on method validation and transfer. It provides guidance on h
 ow to perform QC analytical test method validations and transfers.\nWh
 y Should You Attend:\nThis course provides guidance on how to perform 
 QC analytical test method validations and transfers. One of the most c
 ritical factors in developing and marketing pharmaceutical drug substa
 nces and drug products is ensuring that the analytical methods used fo
 r analysis can generate valid data upon which business and regulatory 
 decisions can be made. FDA, ICH and USP have each recognized the impor
 tance of this relative to the drug development process and have each e
 xpanded method validation requirements in recent years. However, with 
 only limited guidance, industry has been left to interpret how to adeq
 uately comply with the regulations. This course provides a comprehensi
 ve overview of the international regulatory authority requirements and
  expectations for test method validation of these assays. This course 
 will prepare attendees with the knowledge and tools to plan and execut
 e test method validation packages for the NDA, BLA and MAA market appl
 ication dossiers, covering in-process, release and stability assays co
 mmonly used by QC.\n\nAreas Covered in the Webinar:\n\n\nTopic 1: Regu
 latory Requirements/Guidance on\n\n\n\nThis course will provide a thor
 ough review of regulatory guidelines on method validation and transfer
 . Each element required to have a complete and thorough method validat
 ion will be discussed in detail to ensure course attendees have a clea
 r understanding of each requirement.\n\n\n\nTerminology defined: quali
 fication, validation, revalidation and verification\nFDA, EMA, ICH req
 uirements and guidance\nValidation lifecycle for analytical methods\n\
 n\nTopic 2: Analytical Method Pre-Validation – Stage 1\nAnalytical T
 arget Profile (ATP)\nICH Q8, Q9 and Q10 adherence - Pre-Validation Req
 uirements\nQC instrumentation qualification\nTraining\nCritical assay 
 reagent qualification\n\n\nTopic 3: Analytical Method Validation Chara
 cteristics – Stage 2\nSpecificity, accuracy, precision, linearity, r
 ange\n\n\n\nWho Will Benefit:\n\nAnalytical Development\nQuality Assur
 ance\nQuality Control\nValidation\nRegulatory Affairs\n\n\nFor more in
 formation visit https://medtechiq.ning.com/events/analytical-method-va
 lidation-and-transfer
DTSTART;TZID=America/New_York:20220223T100000
DTEND;TZID=America/New_York:20220223T130000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/analytical-method-validation-
 transfer-webinar-training-706186-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/analytical-method-validation-tran
 sfer-webinar-training-706186-prdw?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/10052919499?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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