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DTSTART:19700308T020000
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UID:2140535:Event:67273
DTSTAMP:20260411T113909Z
SUMMARY:Webinar on Sample Size and Statistical Rationale for Medical D
 evice Packaging Validations
DESCRIPTION:Overview: Compliance to ISO 11607, Parts 1 and 2 require t
 hat Packaging Validations include the development of a statistical rat
 ionale to support the testing conclusions of sterile barrier systems a
 nd packaging processes. Learn the basics of a process for developing a
  validation statistical rationale for packaging sterile barrier system
 s and processes.\nAreas Covered in the Session:\nStatistical Rationale
 s-the importance and application of developing an appropriate sample s
 ize for testingCompliance and guidance for:Medical device sterile barr
 ier systemsDetermining sample size for sterile barrier systems (packag
 ing systems)A process for developing an appropriate and statistically 
 valid test populationSummary of key takeaways of non-statistically sig
 nificant survey of medical device companies on statistical rationalesW
 rap UpQuestion and answer\nWho Will Benefit:\nPackaging and Quality En
 gineersPackaging and Quality ManagersTest Engineers\nSpeaker Profile:\
 nKaren K. Greene is currently Vice President, Life Packaging Technolog
 y LLC, a packaging engineering consulting and services firm. She has b
 een a packaging engineering industry professional for over 30 years. M
 s. Greene holds a Bachelor of Arts, Biology, degree from Holy Cross Co
 llege in Worcester, MA and a professional certificate in engineering m
 anagement from University of CA, San Diego. She is a certified packagi
 ng professional, CPP, the Co- President of the southern California Cha
 pter of the Institute of Packaging Professionals and is a committee ch
 airperson of the IoPP Medical Device Packaging Technical Committee. Ms
 . Greene is a member of the ASTM F02, Flexible Barrier Packaging commi
 ttee. She is an ISTA 7E (thermal design and validation) certified audi
 tor.\nContact Detail:\nNetZealous - Compliance4All,161 Mission Falls L
 ane, Suite 216,Fremont, CA 94539, USA.Phone: +1-800-447-9407Email: sup
 port@compliance4All.comhttp://www.compliance4all.com/Event Link : htt
 p://bit.ly/1Xo2XVW\n\nFor more information visit https://medtechiq.nin
 g.com/events/webinar-on-sample-size-and-statistical-rationale-for-medi
 cal
DTSTART;TZID=America/New_York:20160118T100000
DTEND;TZID=America/New_York:20160118T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:
URL:
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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