Manufacturing Facility Design for Global Organizations
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.
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
- 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