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DTSTART:19700308T020000
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UID:2140535:Event:470543
DTSTAMP:20260515T185449Z
SUMMARY:Statistical Elements of Implementing ICH Guidelines
DESCRIPTION:Why Should You Attend:\nMost organizations have programs a
 nd procedures but they contain holes or fall short in the implementati
 on of the tools and techniques used to apply proper statistical reason
 ing and analysis to ICH guidelines. Statistics can help you to better 
 understand, implement, and track processes covered by the ICH guidelin
 es?\nThis 2-day seminar explores the unique challenges facing quality 
 functions of pharmaceutical and biotechnology companies. Attendees wil
 l learn practical implementation solutions as well as best practice de
 scriptions that will allow management to effectively assess, manage an
 d mitigate risk of poorly designed studies. Participants will learn st
 atistical methods related to ICH guidelines and will discover how regu
 latory agencies, such as the FDA expect organizations to meet these gu
 idelines.\nThis seminar will provide attendees with an understanding o
 f the fourteen ICH Quality guidelines as relates to statistical guidan
 ce and analysis. The course will provide tools, techniques and insight
  that will allow participants to immediately begin implementation of t
 he information learned within their organization/firm.\nLearning objec
 tives:\nUpon completion of the course, you will be able to:\n\nCompare
  FDA requirements to ICH guidelines.\nPerform comparative analyses and
  regression analysis.\nKnow the difference between confidence and tole
 rance intervals.\nCalculate the appropriate sample size.\nCalculate th
 e probability of risk.\nDefine and implement a process characterizatio
 n strategy\n\nAreas covered:\nDay 1:\n\nReview ICH Quality Guidelines 
 (Q Series)\nQ1 Stability Testing\nQ2 Analytical Validation\nQ3A-3E Imp
 urities\nQ4 Pharmacopoeias\nQ5A-5E Quality of Biotechnological Product
 s\nQ6A-6B Specifications\nQ7 Good Manufacturing Practice\nQ8 Pharmaceu
 tical Development\nQ9 Quality Risk Management\n\n\n\nWho will Benefit:
 \n\nQuality Managers\nAssay Development Scientists\nQuality Analysts\n
 Research Scientists\nRisk Managers\n\n\n\n\n\n\nFor more information v
 isit https://medtechiq.ning.com/events/statistical-elements-of-impleme
 nting-ich-guidelines
DTSTART;TZID=America/New_York:20220119T100000
DTEND;TZID=America/New_York:20220120T160000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/statistical-elements-implemen
 ting-ich-guidelines-seminar-training-80018SEM-prdsm?channel=MedTech%20
 I.Q
URL:https://www.complianceonline.com/statistical-elements-implementing
 -ich-guidelines-seminar-training-80018SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9829224063?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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