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

Continuing professional education session from Compliance4All

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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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