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Developing Specifications for Drug Substances and Drug Products

 
  January 20, 2014  
     
 
CfPA - The Center for Professional Advancement, Burlingame, CA
June 2-3, 2014


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.; Mallinckrodt Pharmaceuticals

Ernest Parente, Ph.D. is Sr. Principal Analytical Chemist in the R&D Product 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 Hoffman-La Roche. He has served at the USP for over 12 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. 

John Michael Morris, Ph.D.; Irish Medicines Board (IMB)

John Michael Morris, Ph.D. is Senior Scientific Advisor at the Irish Medicines Board (IMB) in Dublin, Ireland. Dr. Morris was formerly Pharmaceutical Director, IMB, responsible for the assessment of quality data (CMC data) and before that Senior Pharmacist at the Irish National Drug Advisory Board. Prior to this, he was a Research Pharmacist at Sterling Winthrop R&D. Dr. Morris obtained a Ph.D. from the University of Manchester (UK). Dr. Morris was the EU member of the ICH Q6A Expert Working Group, and in 2003 led the Group for the revision of the ICH Guideline Q3B. He was a member of the CPMP/CVMP Quality Working Party until 2003, and in 2004 was elected to the position of Chairman of the European Pharmacopoeia Commission. Currently he remains a member of the European Pharmacopoeia Commission and is still active in ICH being Rapporteur (Chair) and EU topic leader for Q4B-pharmacopoeial harmonization. 
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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