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TZOFFSETFROM:-0500
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DTSTART:19700308T020000
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UID:2140535:Event:72482
DTSTAMP:20260519T055348Z
SUMMARY:Statistical Concepts of Process Validation - 2017
DESCRIPTION:Overview:Process validation is an important element in med
 ical device manufacturing. This presentation looks at the underlying s
 tatistical concepts to perform an effective process validation.Why sho
 uld you Attend:If you conduct process validation, you need to ensure t
 hat your results are valid. Beyond the regulatory requirements, statis
 tical approaches will help you achieve the desired result - processes 
 that produce only conforming material. This presentation provides the 
 background you need on the statistical approach to process validation.
 Areas Covered in the Session:Understand the QSR requirements for proce
 ss validationExplain the FDA's approach as documented in Warning Lette
 rsUnderstand the ISO 13485:2016 requirements for process validationSta
 te the statistical model that links process input and process outputLi
 nk sampling verification to the process modelWho Will Benefit: Quality
  EngineersProduction ManagersProduction SupervisorsManufacturing Engin
 eersProduction EngineersDesign EngineersProcess OwnersSpeaker Profile:
 Dan is the President of Ombu Enterprises, LLC, a company offering trai
 ning and execution in Operational Excellence, focused on analytic skil
 ls and a systems approach to operations management. Dan has more than 
 30 years experience in quality, operations, and program management in 
 regulated industries including aviation, defense, medical devices, and
  clinical labs.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-
 800-447-9407Email: support@compliance4All.com\n\nFor more information 
 visit https://medtechiq.ning.com/events/statistical-concepts-of-proces
 s-validation-2017
DTSTART;TZID=America/New_York:20170705T100000
DTEND;TZID=America/New_York:20170705T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1365LIVE?channel=medtechiq.ning_Jul_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501365
 LIVE?channel=medtechiq.ning_Jul_2017_SEO
CONTACT:18004479407
ORGANIZER:Netzealous LLC DBA - Compliance4All
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562015312?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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