Conference about Sample Size and Statistical Rationale for Medical Device Packaging Validations

Website http://bit.ly/1Xo2XVW | Edit Freely

Category Medical Device; Statistical Rationale; Packaging Validations

Deadline: January 17, 2016 | Date: January 18, 2016

Venue/Country: Online Event, U.S.A

Updated: 2015-11-30 18:37:19 (GMT+9)

Call For Papers - CFP

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

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.

Contact Detail:

NetZealous - Compliance4All,

161 Mission Falls Lane, Suite 216,

Fremont, CA 94539, USA.

Phone: +1-800-447-9407

Email: supportcompliance4All.com

http://www.compliance4all.com/

Event Link : http://bit.ly/1Xo2XVW