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Stability Studies and Estimating Shelf Life - Webinar (Recorded)

  • Webinar
  • 90 Minutes
  • May 2019
  • Compliance Online
  • ID: 4899656
Why Should You Attend:

It is essential for manufacturers of foods, drugs, consumer goods, and other products to determine the shelf life of their products. It will help customers identify when the product can be expected to perform as intended. There are many methods to quantify the “shelf-life” of a product. The Method(s) selected are often based on the testing duration available.

In this webinar you will learn the steps involved in setting-up a stability study and in analyzing the results to evaluate the product’s shelf life. How regression models are used to model the relationship between the response variable(s) and time will be presented. Methods for handling non-normal response data will also be discussed. Finally, how accelerating variables can be used to shrink the study time and the models required will be introduced. Many examples that illustrate the methods will also be presented.

This program will cover the following topics:

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

Areas Covered in the Webinar:

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

Speakers

Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. He 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.

Mr. Wachs is currently a Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity. He also possesses expertise in the application of reliability methods to achieve robust and reliable products as well as estimate and reduce warranty. Mr. Wachs regularly speaks at industry conferences and provides workshops in industrial statistical methods worldwide.

He has an M.A. in Applied Statistics from the University of Michigan, an M.B.A, Katz Graduate School of Business from the University of Pittsburgh, 1992, and a B.S., Mechanical Engineering from the University of Michigan.