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DTSTART:19700308T020000
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UID:2140535:Event:469916
DTSTAMP:20260602T083851Z
SUMMARY:Lifecycle Management of Analytical Methods and Procedures acco
 rding to new USP and ICH Guidelines
DESCRIPTION:Results of analytical methods are used as the basis for im
 portant decisions during development and manufacturing of pharmaceutic
 al products. All regulatory agencies expect the regulated industry to 
 have procedures in place to ensure suitable levels of reliability, acc
 uracy and precision of such methods. The procedures should cover lifec
 ycle phases from design, development, validation to on-going routine u
 se.\nManaging analytical methods and procedures according to the lifec
 ycle approach has been recommended in recent FDA guidance documents an
 d stimuli articles published by the USP. For example, the recent FDA g
 uidance “Analytical Procedures and Methods Validation for Drugs and 
 Biologics” contains a section on Lifecycle Management of Analytical 
 Procedures.\nThis 2-day workshop will explain the background to the ne
 w Analytical Procedure Lifecycle guidelines and give attendees the kno
 wledge needed to implement recommended approaches. Interactive exercis
 es will be included in the workshop.\n\nLearning Objectives:\n\nLearn 
 about the regulatory background and recommendations for managing the l
 ifecycle of analytical methods and procedures\nUnderstand current and 
 future industry trends: the concept of lifecycle management of analyti
 cal methods, recent ICH guidance (ICH Q12), proposed USP General Chapt
 er <1220> (Analytical Procedure Lifecycle) and Quality by Design (QbD)
  principles for method development and validation\nLearn how to plan, 
 execute and document design, development and validation of methods dev
 eloped in-house\nUnderstand the principles of lifecycle management for
  compendial procedures and for managing method transfer\nBe able to de
 velop a strategy for analytical procedure lifecycle management\nUnders
 tand risk management strategies throughout the procedure lifecycle\nUn
 derstand the concept of measurement uncertainty\n\nWho will Benefit:\n
 \nQA managers and personnel\nQuality control scientists\nMethod develo
 pment scientists\nAnalytical chemists\nValidation specialists\nLaborat
 ory managers and supervisors\nRegulatory affairs professionals\nTraini
 ng departments\nDocumentation departments\nConsultants\n\n\nFor more i
 nformation visit https://medtechiq.ning.com/events/lifecycle-managemen
 t-of-analytical-methods-and-procedures-1
DTSTART;TZID=America/New_York:20211216T100000
DTEND;TZID=America/New_York:20211217T170000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/analytical-methods-procedures
 -lifecycle-management-fda-usp-seminar-training-80616SEM-prdsm?channel=
 MedTech%20I.Q
URL:https://www.complianceonline.com/analytical-methods-procedures-lif
 ecycle-management-fda-usp-seminar-training-80616SEM-prdsm?channel=MedT
 ech%20I.Q
CONTACT:1-888-717-2436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9640218892?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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