A key component of pharmaceutical, medical device and biotechnology product development is to determine product stability and shelf life. The basic statistical assumptions, tests and life predictions 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.
This course 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.
ESDA is a recommended course prior to taking this course.
Extendibility and Confidence Intervals
Shelf Life Determination
All batches pooled
All batches with individual fits