Stability Analysis

Course Description

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 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.

Audience

This Course is designed for all scientist, 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.

Prerequisites:

Engineering Statistics and Data Analysis is recommended

8 Hours

Contact Information

Email
paulette@pyyoungassociates.com

Phone
1 (650) 967-2700

Address
P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Objectives

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

• Design and analyze stability studies
• Determine the appropriate fitting method for any stability data set • Determine shelf life
• Select appropriate analysis technique based on type of data
• Use and interpret the stability script and associate report

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