2014 ISPE Aseptic Conference

Barrier Isolation and RABS

Track Leaders:

 PhotoJack Lysfjord
Principal Consultant, Lysfjord Consulting LLC, USA

 PhotoRyan Hawkins
Vice President of Operations & COO, Cook Pharmica, USA

Learn from industry experts and experience in designing, qualifying and operating Barrier Isolator and Restricted Access Barrier Systems (RABS) for aseptic processing. Understand how new technology is being utilized and leveraged for improved efficiency, compliance, and cost effectiveness. Best practices and multi-national considerations will be shared through relevant case studies.

Hear from user companies and regulators regarding approaches and systems working to maintain effective Aseptic Processing.

Barrier Isolation and RABS Track Participants will:

  • Hear case studies for barrier line replacement, flexible fillers, containment and from experienced system users
  • Compare and understand differences between design, installation and operating RABS vs. Isolators
  • Participate, learn and benchmark best practices from presentations and discussion groups covering industry trending challenges
  • Get your questions answered by FDA for acceptable practices and how regulatory expectations are shifting
  • Learn where aseptic processing has been, where it is now and be a part of where it is going

View the Track Agenda ( 157 KB)

Welcome and Introduction

Charlotte Enghave Fruergaard, Ph.D., Partner, Global Consulting, NNE Pharmaplan, Denmark

Keynote Presentation

Thomas Arista, Investigator/National Expert, Biotech, FDA/ORA/ORO/DDFI, USA

Rick Friedman, Associate Director, Office of Manufacturing and Product Quality, FDA/CDER, USA

View Other Tracks:

Aseptic Processing Technologies and Disposables

Regulatory Panel

Announcements:

Handouts are now available!