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Course ID:
599

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Drug Product Stability and Shelf-Life
December 09 - 11, 2009
Burlingame, CA

Online Registration is not available at this time. Click on the Notify Me button to the left to be notified when online registration is available.

This course is available as a client site course. Please click here for more information.

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

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.

Other Courses of Interest

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Developing Specifications for Drug Substances and Drug Products
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Excipient GMPs

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ICH-Q7
Jun 25 2012
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Lyophilization Technology
Mar 12 2012
, Amsterdam, The Netherlands

Lyophilization Technology
Apr 23 2012
, New Brunswick, NJ

Microencapsulation and Particle Coating

Sterile Products: Formulation, Manufacture and Quality Assurance
Jun 12 2012
, Burlingame, CA


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