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DTSTART:19700308T020000
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UID:2140535:Event:470518
DTSTAMP:20260531T112709Z
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.\nLearning Objectives:\n\nLearn ab
 out the regulatory background and recommendations for managing the lif
 ecycle of analytical methods and procedures\nUnderstand current and fu
 ture industry trends: the concept of lifecycle management of analytica
 l methods, recent ICH guidance (ICH Q12), proposed USP General Chapter
  <1220> (Analytical Procedure Lifecycle) and Quality by Design (QbD) p
 rinciples for method development and validation\nLearn how to plan, ex
 ecute and document design, development and validation of methods devel
 oped in-house\nUnderstand the principles of lifecycle management for c
 ompendial procedures and for managing method transfer\nBe able to deve
 lop a strategy for analytical procedure lifecycle management\nUndersta
 nd risk management strategies throughout the procedure lifecycle\nUnde
 rstand the concept of measurement uncertainty\nBe able to justify and 
 document decisions about type and extend of revalidation after method 
 changes\nBe able to define and demonstrate FDA, EU, USP and ICH compli
 ance to auditors and inspectors\n\nWho will Benefit:\n\nQA managers an
 d personnel\nQuality control scientists\nMethod development scientists
 \nAnalytical chemists\nValidation specialists\nLaboratory managers and
  supervisors\nRegulatory affairs professionals\nTraining departments\n
 Documentation departments\nConsultants\n\n\nFor more information visit
  https://medtechiq.ning.com/events/lifecycle-management-of-analytical-
 methods-and-procedures-2
DTSTART;TZID=America/New_York:20211216T100000
DTEND;TZID=America/New_York:20211217T170000
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/9758918459?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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