This course presents an approach for integrating the techniques outlined in FDA regulations and ICH guidelines into your stability program. Specifically, the course 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 Formats available Duration
: 7 hours/180 days license

Before attending this course, you should

• complete the

course or have equivalent experience * complete the
course or have equivalent experience * have some knowledge of the basic tenets of stability testing for drug substances or products.

This course addresses JMP software.

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

EJSTN12.