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Drug Product Stability and Shelf-Life

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Overview / Abstract:

Who Should Attend?
This course contains in-depth coverage of the science and practice of drug stability, 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

Course 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.


Jun 08, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.8 CEUs



Presenters / Authors / Faculty

Dr. Pardeep K. Gupta; Professor of Pharmaceutics, Philadelphia College of Pharmacy, University of The Sciences in Philadelphia (USP)

Dr. Pardeep K. Gupta is a Professor of Pharmaceutics in Philadelphia College of Pharmacy at the University of The Sciences in Philadelphia (USP). He received his B. Pharm. and M. Pharm. (pharmaceutical chemistry) degrees from India. He also received a M.S. degree in medicinal chemistry from USP and his Ph.D. in pharmaceutics from University of Wisconsin. His research interests include delivery of proteins and peptides and study of the interaction of drugs with biomembranes. He has published several articles and has authored several book chapters. His teaching responsibilities include courses in solubility, controlled drug delivery and drug stability at the graduate level. He is on the editorial board of Remington: The Science and Practice of Pharmacy, and is the editor of Pharmaceutical Chemistry and Pharmaceutical Testing, Analysis and Control sections of the book.

Keywords / Search Terms

CfPA drug stability, shelf-life, pharmaceutical, biotechnology, cosmetic, Degradation, packaging, analytical methodology, data analysis, data management, FDA Stability guidelines, ICH Guidelines Seminar CE CME

LIVE Activity Location Details

06-06-2018 - 06-08-2018

New Brunswick
United States of America

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