Current Trends in Disposable Applications (Session 301)

Tuesday 8 November 08.15 – 11.30

ISPE CEUs: 0.23

In these circumstances, disposable technologies may have greater application for high throughput, low cost clinical screening of potential drug candidates. There are a number of issues that need to be resolved for Phase 0 / 1 production. This seminar will address the following: Compatibility issues, component interchangeability, supply chain risk, integrity of disposable systems and environmental monitoring challenges; advances in technologies for downstream processing; development of a combined roadmap for successful implementation from phase one to commercial manufacturing.

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

How You Will Benefit

Understand the technical tools available for evaluation in the implementation of disposable technologies
Apply risk management methodology for evaluating disposable technologies
Analyze disposables and their operational use in varied clean room air classifications
Understand disposable choices currently available by varying industry vendors for phase one manufacturing

Who Should Attend

Professionals from engineering, Process development, Manufacturing, Validation, and Procurement

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

API, Biotech, Disposables, Sterile Products Processing, and Sustainable Facilities