Stability Studies and Estimating Shelf Life
Duration: 75 Minutes
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.
Objectives of the Presentation
Why Should you Attend
- Use of traditional reliability methods (e.g. Weibull analysis based on testing until failure) to estimate the time at which the specified percentage fail at a specified confidence level)
- The use of regression models to extrapolate to predict shelf life for a product. When testing cannot be done until failure but extrapolation is needed
- We talk briefly about methods that can be used when the response data is not normally distributed since standard regression models assume normality
- Finally, some ideas on the use of accelerated testing to get results more quickly. i.e. the use of an accelerated life test model to take data from accelerated conditions and use them to predict results at normal conditions
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 modelling 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.
Who will Benefit
- Planning a Stability Study
- Performance Specifications
- Determining Shelf Life
- Confidence Levels
- Regression Modelling (Linear and Non-Linear)
- Handing Non-Normal Response Data
- Introduction to Accelerated Stability Testing
- 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
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.