Sample Size and Statistical Rationale for Medical Device Packaging Validations
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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:
Who Will Benefit:
- 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)
- A process for developing an appropriate and statistically valid test population
- Summary of key takeaways of non-statistically significant survey of medical device companies on statistical rationales
- Wrap Up
- Question and answer
- 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.
Ms. Greene is a lead industry consultant for medical device and pharmaceutical package development, validation and production implementation projects and has solved problems related to sterile barrier package integrity, package design, test method development and test method validation and packaging quality related issues. Her expertise extends to cold chain packaging issues, as well. She has held leadership positions with Edwards Lifesciences and IMED Corporation for teams responsible for packaging engineering, documentation, configuration management and label development functions within the medical device industry.
Ms. Greene is sought after for her expertise in developing action plans for compliance to international packaging regulatory standards as well as solving packaging performance problems. She has authored several articles, presented at numerous conferences and conducted webinars on the topic of medical packaging, statistical rationale development for packaging validations and packaging integrity issues.