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)
- 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
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.
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Event Link : http://bit.ly/1Xo2XVW
Not sure if you want to exhibit at or attend the Webinar on Sample Size and Statistical Rationale for Medical Device Packaging Validations? See the panels below to get the information you need to make an informed decision.
|Conference/Event Dates:||01/18/2016 - 01/18/2016|
|Conference/Event Hours:||60 Minutes|
|Other Industries:||Manufacturing, Medical|
|Cost to Attend:||http://bit.ly/1Xo2XVW...|
|Audience:||One Dial-in One Attendee
|Show Owner:||NetZealous - Compliance4All|
|Sponsorship Details:||NetZealous - Compliance4All|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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