2020 ISPE Continuous Manufacturing Workshop

A New Decade for Continuous Manufacturing: Current Landscape & Future Opportunities 

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 2020 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.


Topics

  • Drug Substance
  • Drug Product
  • Continuous Manufacturing Deployment
  • Continuous API Manufacturing

Learning Objectives

  • 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?

Engineers Engineering Managers & Directors OperationsProcess Engineers PAT SpecialistsValidation SpecialistsRegulatorsPlant Directors & ManagersProject Managers


Program Committee

Christine M. V. Moore, PhD
Global Head and Executive Director, GRACS CMC Policy
Merck & Co.
Chair and Board Ambassador
Gabriella Dahlgren, PhD
Manager, Strategy Deployment and Excellence, PQM
Janssen Supply Group LLC
Kelvin H. Lee, PhD
Prof. of Chemical and Biomolecular Engineering, Univ. of Delaware, and Director
NIIMBL
Michael K. O'Brien, PhD
Founder & President
NGT BioPharma Consultants
Jeffery N. Odum, CPIP
Head of Design, Technology & Standards, Biologics Engineering
Sanofi
Antonio R. Moreira, PhD
Vice Provost, Academic Affairs
University of Maryland, Baltimore County