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CfPA

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.

Expiration

Jun 08, 2018

Discipline(s)

Education (Higher Ed)

Format

Live / Seminar, Seminar

Cost

$2750

Credits / Hours

1.8 CEUs

Accreditation

IACET, AIC, ASQ

Presenters / Authors / Faculty

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

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

Date(s)
06-06-2018 - 06-08-2018

New Brunswick
NJ  
United States of America

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