The Center for Professional Advancement, Boca Raton, FL
December 12-14, 2007
Who Should Attend:
This course contains in-depth coverage of the science and practice of drug stability and shelf-life, and is designed to benefit the following personnel:QC/QA Managers/Supervisors
Product Stability Managers
Manufacturing Personnel
Research & Product Development Scientists and Managers
Regulatory Personnel
Pharmaceutical Consultants
Description:
This course 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.
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