The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.

In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.

This audio conference covers:

• Why regression analysis is the cornerstone of stability testing
• Why R2 is not the be-all-end-all!
• How to pool lots in stability analysis
• Using residual analysis to assess goodness of model fit
• What happens when the slope is not statistically significant

About the speaker:

Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to a variety of industries. Prior to starting Statistical Outsourcing Services, he was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, he was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry.

Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. Mr. Walfish concentrates his efforts on the medical device, pharmaceutical and biotechnology industries. He holds a Bachelor of Arts in Statistics from the University of Buffalo, Master of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

Who should attend?

• Stability Coordinators
• QA/QC
• Quality Engineers
• Quality Managers
• Lab Managers
• Regulatory Affairs