Stability Studies and Shelf Life Estimation (Session 1)

Pre Recorded

  • 105 minutes

A stability study is an analysis that is typically performed to determine the long-term effects of specific storage conditions on a substance or product. This study helps in predicting the product’s shelf Life under given conditions. This part of the course deals with the basic planning of conducting a Stability Study on a product.

Our expert speaker Steven Wachs, will cover some of the early aspects of conducting an efficient stability program, including analyzing basic statistics & confidence levels. He will also discuss the best way to approach the Life Data Analysis to find shelf life.

Session 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

Why You Should Attend:

It will help professionals plan and implement the Stability Study from scratch. This session will introduce the key factor integrity and quality of stability study. It will also explain about the importance of an adequate measurement system and also discuss how these changes can affect the stability program.

Who Should Attend:

  • R&D Personnel

  • Product Development Personnel

  • Quality Personnel

  • Lab Testing Personnel

  • Operations / Production Managers

  • Quality Assurance Managers, Engineers

  • Processor 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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