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UID:2140535:Event:81093
DTSTAMP:20260530T163147Z
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.\
 n\n\n\nAreas Covered in the Session :\n\nWhy an organization needs cha
 nge control\nHow change control fits into the pharmaceutical quality s
 ystem\nThe change control process\n\n\n\n\n\nWho Will Benefit:\n\nSeni
 or management\nMiddle management\nline personnel\nQuality Assurance pe
 rsonnel\n\n\n\n\n\nAbout Speaker:\nJohn G. (Jerry) Lanese is an indepe
 ndent consultant with a focus on Quality Systems and the components of
  an effective Quality System. He received a BA and MS from Middlebury 
 College and a Ph.D. in Analytical Chemistry from the University of Mic
 higan and began his career teaching Analytical Chemistry in a small li
 beral arts college. Dr. Lanese moved from the academic environment to 
 the pharmaceutical industry where he has managed Analytical Research, 
 Quality Control and Quality Assurance functions.\n\n\n\n\n\n\nFor more
  information visit https://medtechiq.ning.com/events/webinar-on-ich-q-
 10-change-management-system-1
DTSTART;TZID=America/New_York:20181206T130000
DTEND;TZID=America/New_York:20181206T143000
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/2562017949?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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