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DTSTART:19700308T020000
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UID:2140535:Event:470510
DTSTAMP:20260530T055731Z
SUMMARY:Analytical Method Validation, Verification and Transfer
DESCRIPTION:Reliable analytical results are necessary to make informed
  decision about the quality and safety of the products in the pharmace
 utical industry. In addition, such analytical data are required for 
 regulatory submissions in support of the drug product registrations. T
 herefore, meaningful experimental designs including system suitability
  parameters must be planned for the intended use of the procedure.\nIn
  this course, general guideline for the determination of the analytica
 l characteristics for different types of validation procedures is hi
 ghlighted for the analysis of both the drug substance and drug product
 . The factors to consider for verification of the compendial procedur
 es will also be discussed. In addition, different approaches for theÂ
  transfer of analytical procedure from one lab (transferring) to othe
 r lab(s) (receiving) under different circumstances will be covered. Ot
 her related topics for obtaining reliable data will also be discussed.
  These topics include analytical instrument qualification as well as
  how to set, handle and monitor specifications.\nDue to global nature 
 of pharmaceutical industry, other quality topics on both regulatory (I
 CH) and compendial (USP) harmonization are also covered. These topics 
 are valuable for scientists directly or indirectly involved with the d
 rug development, analysis. stability studies or regulatory/compendial 
 submissions.\nLearning Objectives:\n\nDrug Approval Process and Regula
 tory Requirements (private standards)\nPharmacopeias and Compendial Ap
 proval Process (public standards)\nCompendial Harmonization Process\nC
 hromatography System Suitability Requirements\nAllowed Adjustments of 
 Chromatographic System Parameters\n\nWho will benefit:\nPharmaceutical
  Industry, Contract Laboratories (CRO), government (FDA or regulatory 
 authorities), Academia (pharmacy, Pharmaceutical, Chemistry)\n\nAnalyt
 ical/Chemists\nFormulation Chemists\nLab Supervisors and Managers\nQC 
 Managers and Personnel\nQA Managers and Personnel\nRegulatory Personne
 l\nCompendial Liaisons\n\n\nFor more information visit https://medtech
 iq.ning.com/events/analytical-method-validation-verification-and-trans
 fer
DTSTART;TZID=America/New_York:20211208T090000
DTEND;TZID=America/New_York:20211209T160000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/pharma-analytical-method-vali
 dation-seminar-training-80595SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/pharma-analytical-method-validati
 on-seminar-training-80595SEM-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/9754834079?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
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