|
 
INTRODUCTION
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product under specified storage conditions.
This course will survey and explore the numerous issues concerning drug substance and drug product stability. The relevance of the ICH Q1 series of guidelines and other sources will be examined. Delegates will learn how to set up scientifically sound stability protocols, generate good stability data, learn how to evaluate it and predict shelf lives for drug products.
Topics to be covered include;
- Overview of Stability Testing
- The ICH and other Guidelines
- Stability Testing for Drug Substances and Stress Testing
- Stability Testing for Drug Products
- Stability Plans & Protocols
- Validated Analytical Methods and Procedures
- Stability Testing for Existing Products and Line Extensions
- Bracketing and Matrixing approaches for Reduced Stability Testing
- Evaluation of Stability Results – Statistical Considerations
- Evaluation of Stability Results, Shelf Life Prediction
- Outsourcing of Stability Testing to Contract Laboratories
- Report Formats CTD and Major Authority requirements
WHO SHOULD ATTEND
The conference will be of particular interest to all those who wish to learn about the current issues and approaches surrounding the presentation and evaluation of stability data including Qualified Persons, analytical chemists and scientists, pharmacists and technical managers actively involved in:
- Analytical Research and Development
- Pharmaceutical Product Development
- Quality Control and Quality Assurance
- Regulatory Affairs/Product Registration
COURSE LEADER
Dr Chris Burgess
Chris Burgess is an internationally recognized expert in the qualification and validation of analytical instrumentation and systems and has 28 years experience in the pharmaceutical industry primarily with Glaxo in Quality Assurance and Analytical R&D. Chris has MSc and PhD degrees from Loughborough University (UK) in Analytical Chemistry.
Chris is
- a Chartered Chemist
- a Fellow of the Royal Society of Chemistry (RSC)
- eligible for nomination as a Qualified Person on the Indicative Register of Analytical Chemists of the RSC
- a Chartered European Chemist
- a qualified ISO/IEC Guide 17025 assessor
Dr. Burgess has published over 60 papers and books in analytical chemistry and analytical science. His most recent book is Valid Analytical Methods & Procedures, a handbook for the Analytical Methods Committee of the Analytical Division of The Royal Society of Chemistry and published in 2000.
PROGRAMME
DAY 1
09.00 - 09.45 Overview of Stability Testing
09.45 - 10.00 Discussion
10.00 - 10.45 The ICH and other Guidelines
10.45 - 11.00 Discussion
11.00 - 11.30 Break
11.30 - 12.15 Stability Testing for Drug Substances and Stress Testing
12.15 - 12.30 Discussion
12.30 - 14.00 Lunch Break
14.00 - 14.45 Stability Testing for Drug Products
14.45 - 15.00 Discussion
15.00 - 15.45 Stability Plans & Protocols
15.45 - 16.00 Discussion
16.00 - 16.30 Break
16.30 - 17.15 Validated Analytical Methods and Procedures
17.15 - 17.30 Discussion
DAY 2
08.30 - 09.15 Stability Testing for Existing Products and Line Extensions
09.15 - 10.00 Bracketing and Matrixing for Reduced Stability Testing
10.15 - 10.30 Discussion
10.30 - 11.00 Break
11.00 - 11.45 Evaluation of Stability Results – Statistical Considerations
11.45 - 12.00 Discussion
12.00 - 12.30 Evaluation of Stability Results, Shelf Life Prediction
12.30 - 12.45 Discussion
12.45 - 14.00 Lunch Break
14.00 - 14.45 Outsourcing of Stability Testing to Contract Laboratories
14.45 - 15.00 Discussion
15.00 - 15.45 Report Formats CTD and Major Authority requirements
15.45 - 16.00 Discussion
16.00 - 16.30 Break
16.30 - 17.00 Panel Discussion (Collected Questions) |
