Course Description:
A key component of pharmaceutical, medical device and biotechnology product
development is to determine product stability and shelf life. In this course, the basic
statistical assumptions, tests and life prediction methods will be presented with examples.
Determination of whether to pool data, use a common slope or fit the data individually
will be presented. Sample size selection and stability estimation in compliance with FDA
guidance is discussed.

Attendees:
Stability Analysis is required for all scientists, engineers and quality professionals who
actively work on all aspects of discovery, product and process development where the
goal is to characterize, optimize and improve product and process performance.

Course Objectives:
Upon completion of the course the participants will be able to:

Prerequisites:  Engineering Statistics and Data Analysis is a recommended
prerequisite for this course.

Detailed Course Outline:

Stability Definition and Introduction                                                 
FDA guidelines
                                                
Stability Study Design
Sample size
Test conditions
                         
Stability Data Analysis and Life Prediction
Extendibility and Confidence Intervals
Shelf Life Determination
All batches pooled
All batches with individual fits
Common slope
Common Intercept
                                                     
Stress Testing