Manufacturing Facility Design for Global Organizations

Session 104
Emerging Markets

Most Pharmaceutical companies have an Emerging market component as part of their strategic plan. This presentation will talk about the considerations and solutions for designing, operating and qualifying a manufacturing facility in China that will be used to manufacture products for sale to the US and Europe.

Session Description

Discuss the considerations in trying to design and construct FDA/EU/WHO compliant manufacturing facilities for the biotech and pharmaceutical industries which also satisfy the regional regulatory requirements for the building. There will be a focus on anticipating both the unique operating considerations and subsequent design solutions to effectively operate in the Chinese market. There will also be a discussion of the differences in facility construction and process utility design.

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

Understand the regional challenges that must be incorporated into facility design
Understand the compliance and regulatory latitude available by FDA and EU in accommodating these requirements

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