Recognizing that high quality production of pharmaceutical products through continuous manufacturing is a timely and important topic for both the regulated agencies and the pharmaceutical industry, the workshop is aimed to provide an open and interactive platform for Indian Pharma players, particularly the generics companies to engage with key experts in the pharmaceutical continuous manufacturing (PCM) arena. Participants will have the opportunity to better understand continuous manufacturing overall know-hows, terminologies, core technologies, and process design-development-validation. They will also have a chance to gain insights from regulated industry representatives on the growing focus of quality manufacturing, and explore how USP can facilitate the adaptation and transition from batch to continuous manufacturing.
Why Attend?
- Understand the fundamental scientific and technical principals of pharmaceutical continuous manufacturing
- Learn the latest development in solid dose products PCM and industrial application
- Explore a roadmap that can help guide pharmaceutical manufacturers in developing transformational strategies and operation of adopting PCM step by step via an 1:1 consultation with experts
- Gain insights into ways that USP can help facilitate the transition to PCM
- Better understand the terminology, technologies, and regulatory aspects of PCM at different markets
Speakers
- Ajaz Hussain, Ph.D., President of the National Institute for Pharmaceutical Technology and Education, University of Cincinnati – Workshop Facilitator and Host
- Ding Ming, Ph.D., Vice President, Research & Innovation, USP
- Fernando Muzzio, Ph.D, Distinguished Professor and Director, C-SOPS, Rutgers University
- Doug Hausner, Ph.D., Associate Director, C-SOPS, Rutgers University
- Bill Randolph. Ph.D., Vice President, Janssen Pharmaceuticals, Johnson & Johnson Companies
- Jaap Venema, Ph.D., Chief Science Officer, USP
- Sau (Larry) Lee, Ph.D., Head of ETT/OPQ/CDER/FDA, US FDA
- Dr. Leslie Weiss, Director, CMC Regulatory Affairs, Johnson & Johnson Companies
Who Should Participate
- Business and scientific leaders and professionals from pharma companies, academic institutions, regulatory bodies, and professional/advocacy organizations
- Vice Presidents, Directors, and Managers who are responsible for pharmaceutical Strategic Development, R&D, Regulatory, Manufacturing, and Quality functions
- Chemical and Biochemical engineers and trainees; QA/QC analysts; Regulatory affairs specialists; and Analytical chemists
- International attendees from India, China, and Asia Pacific areas are particularly welcome
Registration Information
Karthik Iyer R, Associate Director, Strategic Customer Development, USP-India
Phone: +91-9866897377
Email: RKI@usp.org
For event logistics, coordination, and venue information, please contact
Syed Mohammed Arifullah, Manager, Administration, USP-India
Phone: +91-9177661157
Email: SNA@usp.org
Local Area Information
ITC Maratha, Mumbai Sahar Elevated Rd, Sahar, Airport Area, Andheri East, Mumbai, Maharashtra 400099