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UID:2140535:Event:58891
DTSTAMP:20260524T063400Z
SUMMARY:Effective and Compliant Change Control Management - Before, Du
 ring and After Validation - Webinar By GlobalCompliancePanel
DESCRIPTION:Overview: There is a need to implement an adequate formal 
 level of change control during engineering projects (referred to as an
  Engineering Change Control) after the approval of the equipment/syste
 ms specifications in addition to the more formal change control after 
 the qualification of these systems. The Engineering change control pro
 cess will apply through design, construction and qualification up to t
 he point that the system is considered installed/operational. The new 
 Quality Systems guideline from the FDA states that the Quality functio
 n must be involved in the review of the design and subsequent changes 
 to the design of facilities, equipment and systems that may impact the
  product quality.   Why should you attend: Most pharmaceutical compa
 nies focuses on change control management after commercialization but 
 changes must be managed earlier during the design of facilities, equip
 ment and systems in addition to changes implemented during the develop
 ment of the manufacturing processes. The question is: What is the leve
 l of control required at the design/development stages? Who needs to b
 e involved? What are the steps required for the processing of such cha
 nges and the documentation that is required to provide evidence of suc
 h controls?  Course Modules & Content Details:\nSpecifications Change 
 Control - Handling of changes to URS, FRS, Design Specifications and W
 hen do we implement some level of Change control\nDesign Change Contro
 l - Relationship between Design Qualification/Review and Change Contro
 l and Adequate/Practical Documentation Requirements for changes during
  design - handling of drawings\nChange Control during Construction, St
 art-Up and Commissioning\nFormal Change Control Management after Equip
 ment/Systems Qualification\nDefinitions - Like for Like, Emergency/Unp
 lanned vs. Normal/Planned Changes\nApplications for Documentation Chan
 ges\nApplications for Process Changes\nApplications for Changes in equ
 ipment/systems\n\n\n\n Who Will Benefit:\n\nManufacturing\nR&D\nQualit
 y\nValidation\nEngineering\nTop Management\n\n\n\n\nMiguel Montalvo, B
 .S. Chem. Eng., MBA, President, Expert Validation Consulting, has over
  twenty-eight years of professional/management experience in positions
  of increasing responsibility in the areas of Quality, Validations and
  Technical Services within the traditional pharmaceutical, OTC Drugs, 
 cosmetics, dietary supplements, biotechnology.\n\nPrice: $245.00\n\nG
 lobalCompliancePanel\nNetZealous LLC, 161 Mission Falls Lane, Suite 21
 6, Fremont, CA 94539, USA  USA Phone:800-447-9407 Fax: 302-288-6884 we
 binars@globalcompliancepanel.com  http://www.globalcompliancepanel.com
 \nRegistration Link\n\n\n\n\n\nFor more information visit https://medt
 echiq.ning.com/events/effective-and-compliant-change-control-managemen
 t-before-during
DTSTART;TZID=America/New_York:20130502T100000
DTEND;TZID=America/New_York:20130502T113000
CATEGORIES:webinar, healthcare, medical, device, pharmaceutical, clini
 cal
LOCATION:Online Training
WEBSITE:http://bit.ly/17cT7hi
URL:http://bit.ly/17cT7hi
CONTACT:8004479407
ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo
 binson
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011438?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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