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Stability Studies & Estimating Shelf Life with Regression Models

Duration : 90 Minutes

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.
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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 webinar discusses the steps to set-up 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, the use of accelerating variables to shorten the study time and the models required are introduced.  The webinar includes several examples to illustrate the methods discussed.

Course Objectives:

• Provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. 
• Allow participants to immediately apply the methods presented. 
• Allow participants to plan and conduct a stability study
• Allow participants to interpret and communicate the results of a stability study
• Provide several alternate methods for estimating shelf life
• Provide guidelines for implementing successful stability studies 

Why Should You Attend:

The webinar will provide useful methods and techniques for conducting a stability study 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.  

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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