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DTSTART:19700308T020000
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UID:2140535:Event:78546
DTSTAMP:20260413T010947Z
SUMMARY:Webinar On \"Method Validation and Test Method Lifecycle. The 
 application of Lifecycle concepts to test methods\"
DESCRIPTION:\nDescription :\nAnalytical Method Validation should be ap
 proached with a clear understanding of the intended use of the method 
 in mind and an understanding of the application of the intended use th
 rough the lifecycle of the method.  The approach to Analytical Method
  Validation should be consistent with the concepts discussed in a rece
 nt USP stimulus paper and articles published in the USP since the conc
 ept paper.\nObjective :\nThis webinar will help personnel in the Analy
 tical Method Development Laboratory, Quality Control Laboratory and Qu
 ality Assurance understand the evolving expectations for analytical me
 thod validation. The paradigm that test method validation is one exper
 iment performed just before method transfer must be replaced with a pr
 oactive, lifecycle approach that includes the three stages of: Analyti
 cal   This ninety-minute webinar will begin with a review of the USP S
 timulus Article, Lifecycle Management of Analytical Procedures:The dis
 cussion will conclude with a review of the test method characteristics
  of accuracy, precision, linearity, range, specificity, limit of detec
 tion and limit of quantitation and the application of these characteri
 stics through the test method lifecycle.\n\n\n\n\nAreas Covered in the
  Session :\nThe following areas will be covered in this audio seminar.
 \n\nThe USP Stimulus article: Lifecycle Management of Analytical Proce
 dures: Method Development, Procedure Performance Qualification, and Pr
 ocedure Performance Verification.\nThe three stages of test method val
 idation:\nTest Method Procedure Design (development and understanding)
 \nTest Method Procedure Performance Qualification\nContinued Test Meth
 od Procedure Performance Verification.\n\n\nAnalytical Target Profile\
 nTest Method uncertainties\nThe Test Method Types\nTest Method charact
 eristics\n\n\n\n\n\nWho Will Benefit:\nThe following individuals will 
 benefit from this webinar.\n\nPersonnel who have responsibilities in l
 aboratory operations, including Directors, Managers, Supervisors and l
 ine personnel.\nQA, Quality Control and Method Development Directors, 
 Managers and those involved with the development, transfer and use of 
 test methods.\nPersonnel in analytical method development.\nQuality Co
 ntrol Laboratory personnel.\nValidation specialists.\n\n\n\n\n\nAbout 
 Speaker:\nJohn G. (Jerry) Lanese is an independent consultant with a f
 ocus on Quality Systems and the components of an effective Quality Sys
 tem. He received a BA and MS from Middlebury College and a Ph.D. in An
 alytical Chemistry from the University of Michigan and began his caree
 r teaching Analytical Chemistry in a small liberal arts college. Dr. L
 anese moved from the academic environment to the pharmaceutical indust
 ry where he has managed Analytical Research, Quality Control and Quali
 ty Assurance functions. \n\n\n\n\n\n\nFor more information visit https
 ://medtechiq.ning.com/events/webinar-on-method-validation-and-test-met
 hod-lifecycle-the
DTSTART;TZID=America/New_York:20180124T130000
DTEND;TZID=America/New_York:20180124T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:http://bit.ly/2rqXQR7
URL:http://bit.ly/2rqXQR7
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017974?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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