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DTSTAMP:20260526T175304Z
SUMMARY:Webinar On \"ICH Q 10 Change Management System\"
DESCRIPTION:\nDescription :\nThe requirement for the Quality Unit revi
 ew and approval of document changes is clear in 21CFR211. However, con
 temporary regulatory expectations for the control of change goes well 
 beyond document change review. The expanded expectation for change con
 trol and the Quality Unit responsibilities in the change control proce
 ss was introduced into the FDA regulated industries in 1996 when it be
 came a requirement for medical devices and was part of the proposed am
 endments to 212CFR211. Since that Change Control has been an element o
 f the Quality System approach found in ICH Q10 and related guidances. 
 It is important that all individuals involved in the pharmaceutical in
 dustry understand the expectations for change control in the everyday 
 pharmaceutical firm operations. In this webinar we will discuss the eg
 ulatdory expectations for change control and how change control fits i
 nto the pharmaceutical quality system.Objective :\nThe objective of th
 is webinar is to help individuals working in the pharmaceutical unders
 tand the regulatory requirements for change control and how change con
 trol integrates into the pharmaceutical quality system\n\n\n\n\n\nArea
 s Covered in the Session :\n\nThe evolution of change control into reg
 ulatory expectations\nWhy an organization needs change control\nHow ch
 ange control fits into the pharmaceutical quality system\nThe change c
 ontrol process\n\n\n\n\n\n\nWho Will Benefit:\n\npersonnel at all leve
 ls of a pharmaceutical firm\nSenior management\nMiddle management\nlin
 e personnel\nQuality Assurance personnel\n\n\n\n\n\n\nAbout Speaker:\n
 John G. (Jerry) Lanese is an independent consultant with a focus on Qu
 ality Systems and the components of an effective Quality System. He re
 ceived a BA and MS from Middlebury College and a Ph.D. in Analytical C
 hemistry from the University of Michigan and began his career teaching
  Analytical Chemistry in a small liberal arts college. Dr. Lanese move
 d from the academic environment to the pharmaceutical industry where h
 e has managed Analytical Research, Quality Control and Quality Assuran
 ce functions.  Dr. Lanese focuses on training. He lectures throughout 
 the world and presents training in all formats (lectures, seminars and
  webinars) on a variety of topics related to Quality Systems, GMPs, AP
 Is, training, laboratory operations, calibration, change control, devi
 ations and product reviews for clients and seminar, webinar and confer
 ence providers. Jerry is a member of the Editorial Board of the Journa
 l of GXP Compliance.\n\n\n\n\n\n\nFor more information visit https://m
 edtechiq.ning.com/events/webinar-on-ich-q-10-change-management-system
DTSTART;TZID=America/New_York:20180927T130000
DTEND;TZID=America/New_York:20180927T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=PH001
 12
URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=PH00112
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/2562020924?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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