Course offering number:0812-301
Course ID:
599
Drug Product Stability and Shelf-Life
15-17 December 2008
Amsterdam, The Netherlands
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.