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Developing Specifications for Drug Substances and Drug Products

 
  November 01, 2010  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
14-15 March 2011


Who Should Attend
This course is intended for those who want to improve their understanding of the overall process of developing specifications for drug substance and drug products from generic, OTC and research-based pharmaceutical industries. The course includes both basic and advanced level topics of interest to:

  • Pharmacists
  • Analytical and Pharmaceutical Chemists
  • Staff from Chemical Production Departments
  • QA and QC Professionals
  • Regulatory Affairs Personnel
  • Pre-Clinical Scientists

Description
This 2-day comprehensive course provides a broad overview of the process of establishing specifications through various development stages for drug products and drug substances made by synthesis or by conventional fermentation. The course focuses on the ICH approach for global harmonization. Using practical examples, the importance of understanding “real-life” constraints and regulatory requirements will be highlighted. Attendees will have the opportunity to participate in a hand-on-workshop to practice specification writing skills. The latest activities of the ICH and pharmacopeial harmonization relevant to setting specifications for drug substances and drug products are reviewed. Strategies for addressing Out-Of-Specification (OOS) findings will also be discussed. There will be opportunities to meet with the instructors and network with course participants. An open and interactive learning environment is encouraged throughout the course.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Ernest Parente, Ph.D.; Pharmaceutical Analytical Sciences Expert

Ernest Parente, Ph.D. is Head of Analytical Sciences at sanofi-aventis, US, LLC in Kansas City, MO. Formerly, he was Director of Quality Control for the sanofi-aventis Kansas City site for 10 years. In addition to Quality Control, Dr. Parente has 20 years of experience in analytical R&D and has served as Team Leader for the development of several currently marketed products. Before joining sanofi-aventis in 1989, he held positions in analytical and pharmaceutical R&D on the staff of Wyeth Laboratories, Warner-Lambert and Hoffman-La Roche. For the past ten years, he has served as a USP Expert Committee member for small molecule monograph development and is currently a member of the USP Council of Experts and chair of the monograph development committee for cough, cold, analgesic and cardiovascular products. He has been an Adjunct Assistant Professor in the Graduate School of Pharmacy at the University of Missouri-Kansas City since 1994. Dr. Parente holds a Ph.D. in Analytical Chemistry from the University of Delaware. He is the author of scientific papers on chemical separations and protein analysis and has presented numerous lectures related to pharmaceutical analysis and topics of interest in the pharmaceutical industry.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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