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.
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.