Stability Analysis
Biotech, Pharmaceutical and Medical Device
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.

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Biotech, Pharmaceutical & Medical Device Courses

Systematic product development, Quality by Design courses, consulting services and analytical training for biotechnology, pharmaceutical and medical device industries. QbD provides guidance to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability and control.

Lean Six Sigma

Complete curriculum for new product development, manufacturing and business process performance optimization.

Tools & Templates

Development tools and templates created by Thomas A. Little Consulting have been used by numerous companies to aid and support various aspects of product development, problem solving, data analysis and risk assessment.

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.
Course Objectives
  1. Design and analyze stability studies.
  2. Determine the appropriate fitting method for any stability data set.
  3. Determine shelf life.
  4. Select appropriate analysis technique based on type of data.
  5. Use and interpret the stability script and associated report.
Detailed Course Outline
Section I: Stability Definition and Introduction
FDA guidelines
Section II: Stability Study Design
Sample size
Test conditions
Section III: 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
Section IV: Stress Testing