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DTSTART:19700308T020000
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UID:2140535:Event:468673
DTSTAMP:20260412T184350Z
SUMMARY:Method Development and Validation for Assays Supporting Testin
 g of Biologics
DESCRIPTION:Biologics continue to be a steadily growing component of t
 he pharmaceutical industry. The advent of large molecule therapeutics 
 requires a different perspective on the assays needed to support devel
 opment through preclinical and clinical testing.\nThis 2-day virtual s
 eminar is designed to offer a broad overview of developing and validat
 ing a range of assay methodologies for biologics with specific key ana
 lysis of cell culture, assay variability, and DOE. Specifically, this 
 seminar covers essential concepts related to cell-based potency method
 s, ELISA, and other methods supporting biologics. In addition to poten
 cy methods this seminar addresses immunogenicity methods for preclinic
 al and clinical studies. The format of the seminar offers an examinati
 on of current best practices as well as time to dissect examples of do
 cumentation with emphasis on beneficial systems to consider. Scientist
 s who attend this 2-day virtual seminar will gain knowledge that will 
 be beneficial in helping to achieve well-controlled validated methods.
 \n\nLearning Objectives:\n\nUnderstanding the different requirements f
 or small versus large molecules\nMapping appropriate timelines with de
 cision points\nDesigning, developing, optimizing, and validating key m
 ethods\nPotency methods, other release and stability methods\nPreclini
 cal and clinical methods\nUse of DOE and statistical analysis\nHandlin
 g of critical materials\nProcess monitoring concepts\nAssessment of or
 thogonal methods\nAssessing readiness for validation\nDefining the val
 idation protocol with real-time capture of data analysis\nMaintaining 
 quality through documentation\n\nWho will Benefit:\nBelow titles worki
 ng in biopharmaceuticals, pharmaceuticals, natural products/botanicals
  will be benefited by attending this seminar:\n\nValidation Scientists
 \nQA/QC\nRegulatory Affairs\nLaboratory Managers\nAssay Development Sp
 ecialists\nStatistician\nCMC Titles\nBio Assay\n\n\nFor more informati
 on visit https://medtechiq.ning.com/events/method-development-and-vali
 dation-for-assays-supporting-testing-1
DTSTART;TZID=America/New_York:20210624T090000
DTEND;TZID=America/New_York:20210625T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/method-development-validation
 -assays-supporting-testing-biologics-seminar-training-80492SEM-prdsm?c
 hannel=MedTech%20I.Q
URL:https://www.complianceonline.com/method-development-validation-ass
 ays-supporting-testing-biologics-seminar-training-80492SEM-prdsm?chann
 el=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/8998857862?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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