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Drug Product Stability and Shelf-Life

 
  February 03, 2010  
     
 
CfPA - The Center for Professional Advancement, Dublin, Ireland
31 May-2 June 2010


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.

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Pardeep K. Gupta, Associate Professor of Pharmaceutics, Philadelphia College of Pharmacy, University of The Sciences in Philadelphia (USP)
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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