Stability Studies And Estimating Shelf Life With Regression Models
Participants will be able to plan/conduct a stability study and then analyze the results to predict shelf life. They will also be able to explain the results from a statistical perspective. They will learn different approaches for estimating shelf life and will be in a position to select an appropriate method given the situation and constraints. Participants will learn how to appropriately model the data ensure the models are valid and describe the trend over time. Finally, the participants will be aware of several issues and guidelines that will be useful to keep in mind. Areas Covered Planning a Stability Study Determining Performance SpecificationsDefining and Determining Shelf LifeConfidence LevelsLife Data Analysis Approach for Determining Shelf LifeLife Data Analysis with Accelerated AgingRegression Modeling (Linear and Non-Linear) to Assess Stability/Shelf LifePooling Batches for Stability StudiesValidating Model AssumptionsHanding Non-Normal Response DataIntroduction to Accelerated Stability Testing Issues and AuidelinesWho Should AttendThe target audience includes personnel involved in product/process development and manufacturing: R&D PersonnelProduct Development PersonnelQuality PersonnelLab Testing PersonnelOperations / Production Managers Quality Assurance Managers, EngineersProcess or Manufacturing Engineers or ManagersProgram or Product ManagersWhy Should You AttendThe 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. Topic BackgroundManufacturers 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 is 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.
Participants will be able to plan/conduct a stability study and then analyze the results to predict shelf life. They will also be able to explain the results from a statistical perspective. They will learn different approaches for estimating shelf life and will be in a position to select an appropriate method given the situation and constraints. Participants will learn how to appropriately model the data ensure the models are valid and describe the trend over time. Finally, the participants will be aware of several issues and guidelines that will be useful to keep in mind.
Areas Covered
- Planning a Stability Study
- Determining Performance Specifications
- Defining and 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 and Auidelines
Who Should Attend
The target audience includes personnel involved in product/process development and manufacturing:
- 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
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.
Topic Background
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 is 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.
