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DTSTART:19700308T020000
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UID:2140535:Event:448196
DTSTAMP:20260515T143145Z
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.
 \nLearning Objectives:\n\nUnderstanding the different requirements for
  small versus large molecules\nMapping appropriate timelines with deci
 sion points\nDesigning, developing, optimizing, and validating key met
 hods\nPotency methods, other release and stability methods\nPreclinica
 l and clinical methods\nUse of DOE and statistical analysis\nHandling 
 of critical materials\nProcess monitoring concepts\nAssessment of orth
 ogonal methods\n\nWho will Benefit:\nBelow titles working in biopharma
 ceuticals, pharmaceuticals, natural products/botanicals will be benefi
 ted by attending this seminar:\n\nValidation Scientists\nQA/QC\nRegula
 tory Affairs\nLaboratory Managers\nAssay Development Specialists\nStat
 istician\nCMC Titles\nBio Assay\n\n\nFor more information visit https:
 //medtechiq.ning.com/events/method-development-and-validation-for-assa
 ys-supporting-testing
DTSTART;TZID=America/New_York:20210204T090000
DTEND;TZID=America/New_York:20210205T170000
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
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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