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.
Join this session by expert speaker Steven Wachs, where he 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.
Session Highlights:
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
Why You Should Attend:
This webinar discusses the steps to set-up a stability study and analyzes 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.
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.
** You can buy On-Demand and view it as per your convenience.
Lynn Anderanin
Lynn Anderanin, CPC, CPPM, CPMA, CPC-I, COSC, is the Sr. Director of Coding Education for Healthcare Information Services, a physician’s revenue cycle management company. She has over 36 years’ experience in all areas of the physician practice, and specializes in Orthopedics. Lynn is currently a Workshop and Audio Presenter. She is a former member of the American Academy of Professional Coders (AAPC) National Advisory Board, and has served on several other boards for the AAPC. She is also the founder of her Local Chapter of the AAPC.