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.
Live FDA presentation with Q&A Session via Teleconference!
Hear from Rick Friedman, Destry Sillivan and Tara Gooen during a one-hour question and answer session!
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
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