Stability Management

No drug product enters the marketplace without adequate stability data first. While ICH has harmonized and standardized the approach to performing stability, a number of challenges are still routinely faced while conducting stability testing. Since inadequate stability can lead to product introduction delays, all drug companies need to ensure their programs are acceptable. This 18-hour, accredited training, delivered over four consecutive days focuses on the science and principles concerning stability of pharmaceutical, biotechnology and cosmetic products. Kinetic approaches to chemical stability will be covered and the advantages and limitations of accelerated stability testing will be discussed. Degradation by chemical, physical and microbiological factors will be covered. Data analysis and practical aspects of stability such as the role of packaging in stability will be included. Considerable attention will be given to analytical methodology, data analysis and data management. Current FDA Stability guidelines and ICH Guidelines on stability will be discussed. The course includes a workshop for hands-on experience of data and statistical analysis.