Stability Studies Complete Course webinar

Pre Recorded | Courses

  • 210 minutes

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. Many approaches are available to quantify the "shelf life" and the method(s) chosen often depend on the testing time available.

This complete course discusses the steps to design a stability study and analyze the results to estimate the product's shelf life. The use of regression models to model the relationship between the response variable(s) and time are presented. Models useful for describing non-linear degradation over time are also presented. Additionally, methods for handling non-normal response data are also discussed. Finally approaches for including the effect of other variables on shelf life (such as packaging type, storage conditions) are presented and includes several examples and case studies to illustrate the methods discussed. Datasets will be provided to the class participants so they can follow along with the instructor, as desired.

Our expert speaker Steven Wachs, will discuss the techniques and method in this course that are used to conduct the analysis of resulting data and stability study to estimate shelf life. He will outline five practical tips for better stability monitoring, including requirements of stability studies, best practices for mapping qualification studies.

Session 1 Highlights :

  • Planning a Stability Study (Study Objectives, Identifying Resources)

  • Basic Statistics

  • Determining Performance Specifications

  • Defining & Determining Shelf Life

  • Confidence Levels

  • Importance of Adequate Measurement Systems

  • 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

Session 2 Highlights :

  • Regression Modeling (Linear and Non-Linear) to Assess Stability/Shelf Life (cont’d)

  • Pooling Batches for Stability Studies

  • Validating Model Assumptions

  • Methods for Handing Non-Normal Response Data

  • Introduction to Accelerated Stability Testing

  • Accelerated Stress Factors and Models

  • Sample Size Implications and Guidelines

  • Modeling Shelf Life as a function of other predictors (packaging type, storage conditions, etc.)

Why You Should Attend:

The course will provide useful methods and techniques for conducting a shelf life/stability studies and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed.

Who Should Attend:

  • R&D Personnel

  • Product Development Personnel

  • Quality Personnel

  • Lab Testing Personnel

  • Operations / Production Managers

  • Quality Assurance Managers, Engineers

  • Process or Manufacturing Engineers or Managers

  • Program or Product Managers

*You may ask your question directly to our expert during the Q&A session (15 minutes) which will be conducted after each session.

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 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 to estimate and reduce warranty. In addition to providing consulting services, Steve regularly conducts workshops in industrial statistical methods for companies worldwide.

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