Efficient Design & Analysis of Shelf-Life & Stability Studies

SL1

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Duration : 1.0 day(s)

:: Course Summary

This 1-day workshop uses a variety of case studies to present the most important aspects to consider for a sound determination of product shelf life. Starting from the assessment of the differences between shelf-life and stability studies, participants learn for each type of study how to design efficient experiments to determine the failure time of products accurately. The issues discussed include the timepoint selection, how to handle destructive testing, the experiment size and the choice of samples. The workshop also emphasizes the appropriate ways to analyze life data and to adequately interpret and communicate the results obtained. The principle of accelerated shelf-life testing (ASLT) along with the conditions for a successful use are discussed.
Throughout the session, FDA and other existing guidelines will be discussed.

:: Learning Objectives

Upon completion of this training course, participants will have learned:

The tools available to define shelf-life in a specific context

The specific features of life data

The notion of competing risks and its consequences

What statistical analysis techniques adapted to life data are available

The modeling techniques especially designed for life data

How to interpret results and what the scope of the results are

:: Target Audience

This session is intended for people who want to improve the way to design and analyze shelf-life and stability studies with the increased knowledge of the most recent tools in this field. It is also intended for people who need to evaluate the scope and validity of existing shelf-life and stability studies. Finally, people who want to compare their current practices with the regulatory requirements and recommendations will find the course very useful.

:: Prerequisite

This course introduces the important ideas in statistics and data analysis applied to the field of shelf-life and stability studies. It assumes that participants have no previous knowledge of statistics or that they have not used it for a long time.

:: Notes and Other Information

Some association members are entitled to discounted registration fees. During the online registration process, do not forget to mention the association name, your membership number and the registration fees will be adjusted if you are entitled to a discount.

:: Topics Covered

General Overview of Shelf-Life
- What is Shelf-Life?
- Why Study Shelf-Life?
- Objectives of Shelf-Life Studies
- What are Stability Studies?
- Difference between Shelf-Life and Stability Studies
Introduction to Life Data
- What are Life Data?
- Defining the Event of Interest that Causes the Failure of the Product
- Particularities of Life Data: Censoring, Truncation
- Impact of Statistical Analysis
- Typical Layout of Results
Designing Efficient Studies
- Definition of Study : Objective, Feasibility, Study and Control Populations
- Identification and Selection of Variables and other Measurement Issues: Impact of End of Study Time, Censoring, Competing Risks, Destructive and Non-destructive Testing, Sample Variability
- Experimental Design, Sample Definition, Sample Selection, Sample Size and Statistical Power, Problems Specific to Sensory Evaluation, Dynamic Designs
Statistical Analysis of Life Data

Estimating Time to Event
Analysis of Stability Studies
Analyzing Time to Event Data to Estimate Shelf-Life: Survival Curves
Reasons Why Usual Analysis Methods (ANOVA, Standard Regression) Fail
Goals of Survival Analysis
Non-Parametric Survival Curve Estimation: Kaplan - Meier
Parametric Survival Curve Estimation
Semi-Parametric Survival Curve Estimation: Cox Regression

A Note on Real-Time vs. Accelerated Testing

Why Accelerated Shelf-Life Testing (ASLT) Models?
Principle of ASLT
Key to successful ASLT
Problems in ASLT

Software

:: Course Content

The need for conducting a shelf-life study can stem from several reasons: the quality of products diminish over time, the stability of a product is critical to ensure its success on the market, consumer and/or legislation demands for fresher products. The financial impact of specifying a date of minimum durability must also be considered as the shelf life of a product is directly related to the assessment of risk, i.e. predicting costs occurred by product freshness guarantees. Conducting a shelf-life study can also help manufacturers define and understand the factors which influence the stability of their products while in storage.
The objectives of shelf-life studies are two-fold: one, to determine the shelf-life of the product of interest and two, to increase shelf-life by identifying and optimizing the factors which influence it.
Shelf-life studies are unique and require special attention to be given to: the definition of the event of interest, the measures to be taken, the characteristics of the factors and responses under study (type of variables, presence of censoring or truncation) and the use of an appropriate statistical technique.
To address these issues, this training session emphasizes the understanding of the key elements for setting up an efficient and appropriate shelf-life and stability studies. Concepts discussed include the difference between shelf-life and stability studies, data characteristics, sample size, censoring, truncation and competing risks. The session covers also powerful statistical tools specially designed for the analysis of life data: Kaplan-Meier, Weibull, Cox regression, etc. Survival curves are presented, explained and interpreted through examples and realistic applications.

Upcoming Public Sessions

Location	Date	Language	Seats Left	Price
Melbourne, Australia	Aug. 28, 2008		8	~~CA$750.00~~ CA$500.00	Register
San Francisco, USA	Oct. 23, 2008		6	CA$750.00	Register

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Current Reviews

by Aneta Krzywak:
The course was excellent and well presented. The information presented has helped me re-evaluate goals associated with the shelf life & stability studies carried out. Thanks Natalie!

by Jadwiga Mazur:
The course is excellent and Natalie is a top-notch teacher/trainer who presents all underlying statistical theories in a simple and easy to follow way. I learned a lot in a relatively short time and would recommend this course to everyone interested in this topic

by Sanja Ilic:
The course was excellent and well presented. It provided me with the basic knowledge necessary to set up a sound shelf life study. With my limited stats background, I was still able to follow and participate. Sharing experience with other participants was very valuable. Thanks Natalie!

by anna marin:
The most valuable point emphasized in this workshop was the need to establish a valid, measurable criterion for product stabitly so that the statistical tools and choice of tools can be used effectively and successfully. This key to successful shelf life testing was very well presented.

by Ami Henriques:
This course provides and easy to understand overview of shelf-life and stability testing, specifically focusing on test design and analysis. The instructor, Natalie, presented the information clearly and focused any discussions on specific applications within each of the participants respective companies.

by Sylvia De Long:
This was an excellent easy to understand course. The instructor did a great job of explaining the material in a way that was helpful and direct. If you don't have an indepth statistics background - don't worry - you won't have any trouble understanding the material. I would recommend this class to anyone that is trying to put together a shelf-life or stability program in their company or for research.

by Krish Ganesan:
This course provided the basic framework for doing stability testing & statistical principles behind the testing. After this course, I am more interested in learning further.

by Edward Oamen:
This course provided the insight that I would apply in the design of my future scientific researches and in the performance of the necessary stability studies. Ms. Natalie Rodrigue was an excellent instructor. She was very comfortable teaching the course and easy to listen to. She responded to the questions with good examples.

by Esther Lee:
An excellent overview of shelf-life and stability tests. Some contents discussed during the course made us think of different perspectives when designing for shelf-life determination. Michelle and Natalie make a great team of instructors!

by Karen Gillis:
This course provided the insight that we needed to further develop our teams ability to design stability, and shelf life studies. Natalie's ability to adapt to our groups understanding was superb, her intuition kept the pace of the seminar going as well delivering information to keep all of our attention. Job well done! and Thank you

by Susan Kwan:
This course was excellent knowledge for any one trying to decipher and analyze the intricate experimental design necessary to develop and perform shelf-life. Natalie is an excellent instructor. She presented the information in a clear, concise way .

by Michelle Stranges:
This was an excellent course and very relevant for an upcoming study. Natalie presented information in a clear, logical format that made it easy to understand

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