IoPP Webinar: Determining Appropriate Sample Size for Package Testing
Determining an appropriate sample size for medical device package testing is an essential consideration for anyone pursuing the validation of a sterile barrier system. “How many should I test” is one of the top questions medical device packaging engineers must consider when developing a sterile barrier system validation plan, and applicable regulatory guidance is not definitive or prescriptive. The issue will be discussed in this IoPP webinar.
What you will learn:
-
Understanding compliance and guidance documents for sterile barrier systems.
-
Statistics reference books and articles.
-
How to determine sample size for final packaging system validation.
-
Tips for developing an appropriate and statistical valid test population for SBS validation.
-
A summary of anonymous industry interviews on sample size for sterile barrier system testing (not a statistically valid sample size).
Speaker:
Vice President
Where:
Online
When:
Oct. 16, 2013
1:00 p.m. – 2:00 p.m. Central time
Cost:
IoPP members: Free
Non-Members: $99
Earn 2 points toward IoPP certification by attending this webinar!
