2018 ISPE Continuous Manufacturing Workshop

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.

Featured Topics

  • Communicating and Partnering with Regulators for Successful New Technologies– Industry Experiences 
  • Perspectives on the Implementation of Continuous Manufacturing
  • Control Strategies for Continuous Drug Products: Comparing Approaches to Process Control and Monitoring 
  • Continuous Manufacturing of API – Where we are today and where we’ll be tomorrow
  • Process Verification for Continuous Manufacturing: Drug Product and Drug Substance
  • Quality Systems Considerations and the Impact of PAT and RTRT
  • Development Strategies for Continuous Manufacturing – Drug Product & Drug Substance
  • Continuous Separation & Purification for API
  • OSD Continuous Manufacturing Process/Equipment/Facility: Challenges and Opportunities
  • Future Directions for Advanced Pharmaceutical 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?

  • Engineering Managers & Directors
  • Engineers
  • Operations
  • PAT Specialists
  • Plant Directors & Managers
  • Process Engineers
  • Project Managers
  • Regulators
  • Validation Specialists

Program Committee

Christine Moore Photograph
Chair: Christine Moore, PhD
Global Head & Executive Director
GRACS CMC - Regulatory Policy &
Compendial Affairs
Merck & Co.
Paul Collins Photograph
Paul Collins
Senior Director
Eli Lilly & Co
Celia Cruz Photograph
Celia Cruz, PhD
Director
Division of Product Quality Research
FDA
Lawrence De Belder Photograph
Lawrence De Belder
Senior Principal Engineer
Janssen Pharmaceuticals
Dave DiProspero Photograph
Dave DiProspero
Director of Pharmaceutical
Process Technology
CRB
Doug Hausner Photograph
Douglas Hausner, PhD
Associate Director for Industrial Relations and
Business Development
Rutgers University
Robert Perks, PhD Photograph
Robert Perks
Vice President, Operations
Werum IT Solutions