Barrier Isolation (Track 1)

Focus on technologies applicable to advanced aseptic processing using RABS and barrier isolation by applying best practices from case studies. Hear from speakers from international companies present topics on global importance through multiple case studies, and interactive workshops.

At the conclusion of this session, participants will be able to:

• Understand technologies applicable to advanced aseptic processing using RABS and barrier isolation from actual users and experts
• Interpret regulatory agency perspectives to improve your regulatory submission and approval process
• Identify costs related to the decision for use of RABS or isolators for new and renovated facilities
• Network with others who are working on RABS and isolator projects
• Interact with vendors of RABS, isolators and process equipment for fill-finish of parenteral products

Leaders

Speakers

• Jeff Campie, USA
• Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
• Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
• Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
• Edwin Melendez, Principle Consultant, Parexel, USA
• Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
• Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
• Julian Wilkins, Vice President, PharmaConsult US Inc, USA
• Paul Wreglesworth, Independent Consultant, United Kingdom

• EVENT HANDOUTS

Host Sponsor