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DTSTART:19700308T020000
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UID:2140535:Event:468469
DTSTAMP:20260413T010043Z
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\nBe able to justify an
 d document decisions about type and extend of revalidation after metho
 d changes\nBe able to define and demonstrate FDA, EU, USP and ICH comp
 liance to auditors and inspectors\n\nWho will Benefit:\n\nQA managers 
 and personnel\nQuality control scientists\nMethod development scientis
 ts\nAnalytical chemists\nValidation specialists\nLaboratory managers a
 nd supervisors\nRegulatory affairs professionals\nTraining departments
 \nDocumentation departments\nConsultants\n\n\nFor more information vis
 it https://medtechiq.ning.com/events/lifecycle-management-of-analytica
 l-methods-and-procedures
DTSTART;TZID=America/New_York:20210617T100000
DTEND;TZID=America/New_York:20210618T170000
CATEGORIES:seminae
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: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/8998848452?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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