Stability Studies and Estimating Shelf Life

Steven Wachs

Steven Wachs

Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has extensive experience in the development of statistical models, reliability analysis, designed experimentation, and statistical process control. Steve is currently a...
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90 Mins
Steven Wachs

Product Shelf Life: Stability Study through Various Models to Estimate Shelf Life of a Product

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Expiry dates based on unsubstantiated shelf life claims can introduce significant risk to a company’s success and reputation. Many approaches are available to quantify the "shelf life" and the method(s) chosen often will depend on the testing time available.   
Join this session by expert speaker Steven Wachs to determine the steps required to set-up a stability study as well as understand the results which will estimate the shelf life of a product. The session will be using regressing models that will help in modeling the relationship shared between response variable(s) and the time. Also, other models that are useful in describing non-linear degradation over time as well as methods to handle non-normal response data will be discussed. You will finally learn how to use accelerating variables which will be used to shorten the study time and the models. The webinar also includes various examples to illustrate the models discussed, in a better and more understandable way.
You will understand various useful techniques and methods in this webinar that are used to conduct the analysis of resulting data and stability study to estimate shelf life. It is easy for you to understand and immediately apply these learning. There will be stress on interpretation and communication of result.

Webinar Objectives

Many companies struggle to determine statistically valid shelf life estimates that are needed for establishing expiry dates on products. Common issues include:

  • Using linear models even when they are not appropriate
  • Not accounting for multiple failure modes in the shelf life estimate
  • Basing shelf life on the best estimate rather than an appropriate confidence bound
  • Inadequate planning prior to collecting data
  • Inability to communicate the results correctly

Webinar Agenda

  • Planning a Stability Study
  • Determining Performance Specifications
  • Defining & Determining Shelf Life
  • Confidence Levels
  • Life Data Analysis Approach for Determining Shelf Life
  • Life Data Analysis with Accelerated Aging
  • Regression Modeling (Linear and Non-Linear) to Assess Stability/Shelf Life
  • Pooling Batches for Stability Studies
  • Validating Model Assumptions
  • Handing Non-Normal Response Data
  • Introduction to Accelerated Stability Testing
  • Issues & Guidelines

Webinar Highlights

  • How to correctly define and express the shelf life of a product
  • How to plan for/set up a stability study
  • The use of regression modeling with extrapolation to predict a product’s shelf life
  • The use of alternate methods (life data analysis) for estimating shelf life and when those methods will be useful
  • How to correctly express a shelf life estimate
  • Methods for handling multiple failure modes and their impact on the overall shelf life

Who Should Attend

  • Design Engineer
  • Engineering Manager
  • Quality Engineer
  • Quality Manager
  • Product Engineer
  • Reliability Engineer
  • Program / Product Manager
  • R&D Personnel
  • Lab Testing Personnel
  • Operations / Production Managers 
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