This course focuses on the science and principles concerning the stability of pharmaceutical, biotechnology, and cosmetic products. New 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.
Identity the stability protocols and data acceptable
Design a stability program
Analyze and interpret stability data and write stability reports
Define the scientific and regulatory terminology in stability
Who Should Attend?
Product Stability Managers
Research & Product Development Scientists and Managers
Science and Fundamentals of Drug Stability
Review of Learning Objectives/Introduction
Design of Stability Studies
Data Analysis and Practical Aspects of Stability and Shelf-Life
Practical Outcomes of Stability Studies
Workshop on Data Analysis
Regulatory Aspects of Drug Stability
Role of Packaging in Product Stability
Special Cases of Stability
Analytical Methodology and Data Handling
Computerization of Stability Studies and Data
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