JMP Software: Stability Analysis

Classroom duration: 1.0 day Live Web duration: 2 half-day sessions Please note the System Requirements below. Course fee: $725 EPTO units: 1.4 CEUs: 0.6

This course presents an approach for integrating the techniques outlined in FDA regulations and ICH guidelines into your stability program. This course specifically focuses on the evaluation and statistical analysis of stability data. In addition to the analytical techniques, the course focuses on the motivation behind this approach. A case study is used to demonstrate these principles and the advantages of software tools.

Learn how to

interpret FDA regulations and ICH guidelines concerning stability evaluation
apply those techniques to your stability program
choose techniques that are best for your program.

Who should attend

Scientists and Quality Control personnel conducting stability testing with some statistical training

Expand/Collapse All Expand All Collapse All Print version

Prerequisites

Before attending this course, you should

complete the JMP Software: Statistical Data Exploration course or have equivalent experience
complete the JMP Software: ANOVA and Regression course or have equivalent experience
have some knowledge of the basic tenets of stability testing for drug substances or products.

Course Contents

FDA Regulations, ICH Guidances, and guidance documents from the PhRMA CMC Statistics Group

review Stabilty Expert Team findings for definition of stability and scope of studies
relate requirements in 21 CFR parts to stability assessment and determination of expiry
use ICH guidance Q1A (R2) Stability Testing and New Drug Substances and Products
use ICH guidance Q1E Evaluation of Stability Data

Stability Studies Based on the Product Life Cycle

present a framework for the progression of stability studies
identify necessary stability studies for submissions for pre-clinical, clinical, and commercial batches of drug substances and products

Estimate Expiry from Accelerated Degradation Tests

learn to select and fit a degradation model
learn to extrapolate to long-term storage conditions

Determining Poolability and Verifing Expiry of Clinical and Commercial Batches

learn to use recommended methods
perform simple linear regression and inverse prediction
perform analysis of covariance (ANCOVA)
confidence, prediction, and tolerance intervals

Determining Out-of-Specification Batches and Alerts for Out-of-Trend Batches

learn to use recommended methods such as by time point method, slope control chart method, and regression control chart method

Software

This course addresses JMP.

Course Materials

Classroom: Students attend classroom courses in one of our public training centers. You receive a hardcopy of the course notes and, in some courses, can choose to take home a copy of the course data.

Live Web: Students attend Live Web classes using a Web browser and a telephone and interact with their instructor and fellow classmates in real time. Each student receives an e-mail with instructions on how to join the class three business days before the class begins. The instructions e-mail includes a link to download the course materials. Students need to download and print the course materials prior to class.

System Requirements

For Live Web, you must

review and follow the general system requirements.
complete the course exercises through our virtual lab. The virtual lab allows you to access the software used in class over the Internet, so that you do not need this software on your local machine.
run this test to connect to a virtual lab session. If firewall problems prevent you from connecting to the virtual lab, then you will need the following software installed and configured in your environment to participate in the course exercises:
- JMP Version 7, Microsoft Word, Microsoft Excel, ODBC Driver for Microsoft Excel (Setup Instructions)
  Tip: To ensure that your ODBC Driver for Microsoft Excel is installed and set up properly:
  1. Open JMP.
  2. From the JMP Starter window, click Open Data Table.
  3. Select the Files of type drop down list.
  4. Scroll through the file types until you see Excel Files (.xls).
    If Excel Files (.xls) is included in this list, then your machine is set up to use the ODBC driver for Excel.
    If Excel Files (.xls) is not listed, contact your system administrator for support.

Share Your Thoughts

Not sure if this course suits your needs or which delivery method is right for you? Give us a call at 800-333-7660 or send us e-mail. If you have suggestions for this course or would like for it to be offered at another training facility, let us know by adding to our Interest List.

This page was created using SAS software.

Learning Center

Stay in Touch

Not sure what course to take?

Submit Your Course Requests

On-site Pricing