Analysis of Stability Data

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Next Date

Thu/Fri, 3-4/12/2026

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Participants

3 - 12 

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Duration

2 Days

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Course Form

online, classroom in Basel or in-house

Trainer:
Trainer: Dr. Philippe Solot

He has over 25 years of experience in the application of statistical methods in the process industry. He has coached many training sessions on various topics, including Statistical Quality and Process Control. His wide practical knowledge allows him to make even technical concepts easily understand­able by participants.

Dr. Solot holds an M.Sc. and a Ph.D. in Applied Mathematics, both from the EPFL (Swiss Federal Institute of Technology, Lausanne).

Course Description

Are you in charge of assuring that your pharmaceutical, biotechnological, cosmetic, or food product remains stable during a certain period? This course covers the most common methods for the analysis of your stability data and the reliable estimation of the product shelf life. It is aimed at scientists who work in development and quality assurance and who already have basic statistical knowledge (as provided in “Visualization of Lab Data with Excel”).

What Are You Going to Learn?

The course emphasizes graphical methods and the selection of appropriate statistical models. Methods are explained through practical examples and exercises from the chemical, pharmaceutical, and cosmetic industries, using Excel supplemented with the validated EasyStat macros. The requirements of the ICH guidelines are also covered in detail.

Who Should Attend?

  • Quality managers, chemists, pharmacists and engineers who are responsible for the stability or the quality of products during a fixed period of time

  • Elementary statistical knowledge is assumed (as provided in “Visualization of Lab Data with Excel”).

Course Fees

Standard Fees
  • CHF 795.- per day + 8.1% VAT (incl. course documents and individual participant coaching during the practical exercises) for online courses
  • CHF 865.- per day + 8.1% VAT (incl. course documents, individual participant coaching during the practical exercises, break refreshments and lunch) for classroom courses.
Conditions for the EU

Which Topics Are Covered?

Basic Concepts

  • Data situation

  • Requirements of the ICH guidelines for the execution and evaluation of stability studies

  • Statistical basics

Analysis of Stability Data: Basics

  • Linear regression: parameter estimation and confidence regions

  • Prediction of the stability

  • Prediction of the shelf life

Analysis of Stability Data: Advanced Topics

  • Covariance analysis

  • Batch pooling

  • Consideration of additional factors (e.g. packaging)

  • Bracketing and matrixing

  • Treatment of several responses

Registration Form – Analysis of Stability Data
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CONFIRMDATA1
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Questions about Data Analysis or EasyStat?

We are always at your disposal if you have any questions. Simply call us on +41 61 686 98 77 or use the Contact Form.