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Webinar: Sample Size and Statistical Rationale for Medical Device Packaging Validations

Continuing professional education session from Compliance4All

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.

Webinar Training Date:
Thursday, February 4, 2016 | 1:00PM EST | 60 Minutes

Webinar Description:
Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.

Areas Covered in the Session:

  • Statistical Rationales-the importance and application of developing an appropriate sample size for testing
  • Compliance and guidance for medical device sterile barrier systems
  • Determining sample size for sterile barrier systems (packaging systems)
  • Summary of key takeaways of non-statistically significant survey of medical device companies on statistical rationales
  • Wrap Up
  • Question and answer

Who Will Benefit:

  • Packaging and Quality Engineers
  • Packaging and Quality Managers
  • Test Engineers

Speaker Profile
Karen K. Greene is currently Vice President, Life Packaging Technology LLC, a packaging engineering consulting and services firm. She has been a packaging engineering industry professional for over 30 years. Ms. Greene holds a Bachelor of Arts, Biology, degree from Holy Cross College in Worcester, MA and a professional certificate in engineering management from University of CA, San Diego. She is a certified packaging professional, CPP, the Co- President of the southern California Chapter of the Institute of Packaging Professionals and is a committee chairperson of the IoPP Medical Device Packaging Technical Committee. Ms. Greene is a member of the ASTM F02, Flexible Barrier Packaging committee. She is an ISTA 7E (thermal design and validation) certified auditor.

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