Interest in continuous manufacturing of pharmaceuticals has exploded in the past few years, fueled by the recent regulatory approvals of the first few drug products to be manufactured by this emerging technology. The 2018 ISPE Continuous Manufacturing Workshop will bring together industry practitioners, regulators and academics to discuss the recent successes and remaining challenges for continuous manufacturing of small molecule drug substances and drug products. The conference will provide an in-depth view of the manufacturing technologies and regulatory approaches for successful development, implementation, and lifecycle management of continuous manufacturing both for new molecules and for batch-to-continuous conversions.
Communicating and Partnering with Regulators for Successful New Technologies
Control Strategies for Continuous Drug Products
Continuous Manufacturing of API: Network Capability, Flow Chemistry, and Executing at Commercial Scale
Continuous Process Verification for Continuous Manufacturing: Drug Product and Drug Substance
Continuous Separation and Purification for API
OSD Continuous Manufacturing Process/Equipment/Facility: Challenges and Opportunities
Quality Systems Considerations and the Impact of PAT and RTRT
Development Strategies for Continuous Manufacturing – Drug Product and Drug Substance
Understand the current status of small molecule drug substance and drug product continuous manufacturing efforts
Recognize the supply chain, safety and quality assurance advantages provided by continuous manufacturing
Compare different approaches to continuous manufacturing regarding equipment, measurement tools, and control strategies
Appreciate avenues for enhanced communication with regulators on innovative and emerging technologies
Who Should Attend?
Engineering Managers & Directors
Plant Directors & Managers
Continuous Manufacturing Special Report
Returning for the first time since 2016, the 2018 ISPE Continuous Manufacturing Workshop will feature cutting-edge presentations from diverse industry front-runners, academic leaders, and regulatory experts who have influenced and implemented continuous manufacturing strategies and successfully launched products using the new technology. Download the Special Report from the 2016 ISPE Continuous Manufacturing Conference to get a glimpse of what to expect at this year's workshop.
Deputy Director and Emerging Technology Team Chair, Office of Testing and Research, FDA
Sau (Larry) Lee is currently the Deputy Director for the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), the acting Team Leader of the OPQ Botanical Review Team, and the chair of the OPQ Emerging Technology Team. Larry a
Director, Division of Product Quality Research, FDA/CDER/OPQ/OTR/DPQR
Celia Cruz is the Director of the Division of Product Quality Research in the Office of Testing and Research at FDA. Before joining the FDA in 2010, Celia worked in industry for eleven years, where she led teams responsible for the development and co
Senior VP, Global API and Dry Products Manufacturing, Eli Lilly and Company
Darin joined Eli Lilly & Company in 1987 after receiving an undergraduate degree in chemical engineering from the Rose-Hulman Institute of Technology. His initial assignment was as a Process Design Engineer in Corporate Engineering in Indianapolis In
Vice President, Manufacturing & Quality Learning Center, Eli Lilly and Company
Dr. Huff received his undergraduate degree in chemistry in 1984 from California State University, Chico. He received his Ph.D. from the University of California, Santa Barbara in 1989. He was an NIH postdoctoral fellow at Harvard University from 1989
Doug is the Associate Director for Industrial Relations and Business Development at the ERC for Structured Organic Particulate Systems (C-SOPS) based at Rutgers University. C-SOPS is the largest academically based research center dedicated to product
Deputy Director-Inspection, Enforcement & Standards, Head of Inspectorate, MHRA
Mark Birse is the Group Manager for the MHRA Inspectorate which comprises of over 75 Inspectors covering GCP, GDP, GLP, GMP & GPvP. Mark is a chemistry graduate with an MSc in pharmaceutical sciences and is a Fellow of the Royal Society of Chemistry.
Dr. Matsuda is a pharmacist and a senior scientist for Quality, Pharmaceuticals and Medical Devices Agency (PMDA). Dr. Matsuda received Ph.D. degree in Medicine from Tokyo Medical and Dental University in 2003. He holds a Bachelor of Pharmacy Degree