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Developing Specifications for Drug Substances and Drug Products

  June 01, 2015  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
12-13 October 2015

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

Course 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.; Sr. Principal Analytical Chemist, Mallinckrodt Pharmaceuticals

Ernest Parente, Ph.D. is Senior Principal Analytical Chemist in the Product Lifecycle and Compliance Support group at Mallinckrodt Pharmaceuticals in St. Louis. Formerly, he was the Head of Analytical Science and the Director of Quality Control at Sanofi-Aventis in Kansas City. In addition to his experience in Quality, Dr. Parente has more than 18 years of experience in Research and Development and was the analytical chemistry 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 at Wyeth Laboratories, Warner-Lambert and Hoffmann-La Roche. He has served at the USP for over 14 years and is currently a member of the USP Council of Experts. Dr. Parente holds a Ph.D. in Analytical Chemistry from the University of Delaware. He is an Adjunct Assistant Professor in the Graduate School of Pharmacy at the University of Missouri-Kansas City and is an active member of the ACS, Sigma Xi, AAAS and AAPS. He is the author of scientific papers on chemical separations and protein analysis and has presented numerous U.S. and International lectures on topics related to pharmaceutical analysis and the pharmaceutical industry.


Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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