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