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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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February 11, 2008 |
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The Center for Professional Advancement, Burlingame, CA
May 5-8, 2008
Who Should Attend
This course is intended for personnel from both Generic and Research-based pharmaceutical industries including:- Pharmacists
- Analytical and Synthetic Chemists from R&D
- Staff from Production Departments and from QA and QC
- Regulatory Affairs Personnel
- Pre-Clinical Scientists will benefit from the course by gaining a better understanding of the complexities of the drug development process and of the importance of setting specifications
Description
The course will present a review of the activities that will occur in the process of setting specifications for APIs made by synthesis or conventional fermentation. Critical specification issues for drug substances and drug products will be reviewed, specifically focusing on the interactions and dialogue necessary between analytical and pharmaceutical/ chemical groups during the development of specifications. Using practical examples, the importance of understanding “real-life” constraints and regulatory requirements will be highlighted across a wide variety of drug product formulations. Strategies for Out-Of-Specification (OOS) findings will be discussed. The course will review the latest activities of ICH with respect to specifications for drug substances and drug products. You will benefit in your job by applying facts learned in this course. Increases in productivity will result. An open and interactive environment is encouraged throughout the course.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Goetz E. Hardtmann, Ph.D.; Senior Partner, H&H Consultants
Goetz E. Hardtmann, Ph.D., is former Vice President of Chemical Development for Sandoz Pharmaceuticals. Prior to that position, Dr. Hardtmann was a Section Head of Medicinal Chemistry. Before joining Sandoz he was a Research Associate at the University of Wisconsin. He is currently a Senior Consultant. In this function he is supporting small companies in their efforts to bring new drugs to the market. He assists clients in establishing developmental strategies and focused process R&D, and in the interactions with regulatory agencies. Dr. Hardtmann’s experience includes managing GMP-conforming development and scale-up of synthetic chemical processes. He has interacted extensively with FDA chemists at CDER and is a member of the American Chemical Society. At PhRMA (PMA) he served as a member of the Committee on Rational Specifications for Impurities in Drug Substances.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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