Dr. Atul Dubey
Director of Continuous Manufacturing
U.S. Pharmacopeia
Ph.D., Mechanical Engineering
Lucy L. Botros, M.S.
Scientific Liaison, General Chapters
U.S. Pharmacopeia
M.S. and B.S. in Chemistry from the McGill University, Montreal, Canada
Dr. Fernando J Muzzio
Director of the Engineering Research C-SOPS
Rutgers University
Ph.D., Univ. of Mass. at Amherst, Chemical Engineering
A one-week interactive training course for
technical personnel seeking to gain in-depth understanding of continuous manufacturing.
Location:
Rutgers University
Busch Campus
98 Brett Road,
Piscataway, NJ 08854
Overview
This is a one-week interactive training course for technical personnel seeking to gain direct intuition and in-depth understanding of continuous manufacturing. The participants will get theoretical background through classroom discussions as well as exposure to a fully functional (non-GMP) continuous manufacturing drug product line as well as the associated unit op, material characterization and PAT equipment. The course is developed jointly by USP and C-SOPS (Rutgers University)
Objectives
Upon the completion of this course you will be able to:
• Discuss the similarities and differences between continuous manufacturing and batch manufacturing processes
• Explain continuous manufacturing concepts, including process design and implementation, and continuous manufacturing terminology, including process control, residence time distribution, and flow sheet models
• Describe material properties and correlation between them, process parameters, and relation between critical material properties (CMP) with critical process parameters (CPP) and how their interactions impact the final product critical quality attributes (CQA).
• Identify and understand the functionality of unit operations in continuous manufacturing, including feeders and blenders
• Describe the role and applications of process analytical technology in continuous manufacturing
• Identify current USP Standards that are relevant to continuous manufacturing
• Understand the regulatory aspects of continuous manufacturing
• Understand concepts of quality strategy implementation in continuous manufacturing
Who Should Participate?
Pharmaceutical manufacturing Research & Development scientists and engineers, formulators, PAT scientists, technical services, line operators and Quality Assurance (QA) specialists
Pharmaceutical technology supplier representatives in equipment, instrumentation, ingredient and process controls
Personnel from regulatory agencies and consulting companies
USP Approved Instructors
Dr. James Scicolone
Research Professor at Engineering Research
C-SOPS
Rutgers University
Ph.D., Materials Science and Engineering, New Jersey Institute of Technology
Dr. Ravendra Singh
Research Assistant Professor at Engineering Research C-SOPS
Rutgers University
Ph.D., Rutgers University
Dr. Gerardo Callegari
Associate Research Professor at Engineering Research C-SOPS
Rutgers University
Ph.D., Universidad de Buenos Aires, Argentina
Dr. Douglas Hausner
Associate Director of the Engineering Research
C-SOPS
USP Expert Panel
Rutgers University
Ph.D., Physical Chemistry
Dr. Andres Roman
Postdoctoral Associate at the Engineering Research C-SOPS
Rutgers University
Ph.D., Applied Chemistry, University of Puerto Rico, Mayaguez
Dr. Sonia Modarres Razavi
Postdoctoral Associate at the NSF Engineering Research C-SOPS
Rutgers University
Ph.D., Mechanical and Aerospace Engineering from Rutgers University
Copyright © 2019, All rights reserved.
Our mailing address is:
United States Pharmacopeial
12601 Twinbrook Parkway | Rockville, MD 20852-1790
Phone: +1-301-881-0666 or 00-800-4875-5555 (select Europe)
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• Understand the essential concepts of Continuous Manufacturing such as design and implementation, process controls, residence time distribution (RTD), and flow sheet models
• Have an interactive experience with equipment -
a fully functional research Continuous Manufacturing line which you can view from every angle
• Understand the regulatory aspects of continuous manufacturing and identify current USP Standards that are relevant to continuous manufacturing
• Network with the Continuous Manufacturing experts and early adopters.
Course Fee:
Regular Price: US$5,000
Early Bird Price: US$4,000
Available through April 6, 2020
