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Developing Specifications for Drug Substances and Drug Products

  June 20, 2017  
CfPA-The Center for Professional Advancement, Phoenix, AZ
September 18-19, 2017

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 and regional requirement. 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 hands-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. 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.; Principal Scientist, CMC Consulting, Cardinal Health Regulatory Sciences

Ernest Parente, Ph.D. is currently a Principal Scientist in the Chemistry, Manufacturing and Control Regulatory Sciences group at Cardinal Health in Overland Park, Kansas. Formerly, he was a Sr. Principal Analytical Chemist at Mallinckrodt Pharmaceuticals in St. Louis and 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 15 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.


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John Michael Morris, Ph.D.

John Michael Morris, Ph.D. was Director Scientific Affairs at the Health Products Regulatory Authority (HPRA) of Ireland, in Dublin, Ireland until his retirement at the end of 2015. 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: Jmorbit@cfpa.com
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