Secrets to Successful Manufacturing Facility Projects in BRIC Countries (Session 202)

Monday 7 November, 13.30 – 17.00

ISPE CEUs: 0.25

The session offers insight into planning and executing pharmaceutical projects in emerging countries. The session is aimed at educating the operating companies as well as the service providers contemplating in doing business in emerging countries. It is designed to provide answers to often-asked questions. It includes real life experiences and lessons learned in executing projects in China, India, Brazil, Russia etc.

For US and European companies investing in these countries, executives are constantly assessing the risks of doing business in these countries. There is also a lot of disappointment and unmet expectations at the end of the projects. This session will cover the various risk elements such as financial risks, quality risks, regulatory risks, schedule risks etc. It will also include issues such as cultural differences, quality of local talents, resource constraints, contractual issues including tax related issues, permitting /governmental issues etc. The audience will learn how to plan a project, what to expect during project execution phase, areas of concerns during compliance phases and where projects can go wrong. The sessions will provide solutions to often-asked questions by western hemisphere based companies.

1. Via case studies, speakers will share their experience and lessons learned.
2. Specific discussions on the uniqueness and barriers that are faced during the various phases of Design, Construction and Validation and how to account for and mitigate those risks.
3. It will discuss various procurement methodology and acceptable practices in those countries.
4. It will cover the compliance risks in constructing a facility for export into US and Western Europe.
5. The session will also provide relative construction and engineering cost data in these countries.

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 uniqueness of executing projects in the emerging countries
• Know all the risks associated with executing projects in various emerging countries
• Get to know limitations of local talents
• Understand compliance risks
• Set up projects appropriately and execute projects successfully
• Know the procurement practices
• Learn relative construction and engineering costs in each Country

Who Should Attend

Operating Companies as well as A/E firms planning to build facilities in Emerging Countries, Pharmaceutical Executives, Project Managers, Procurement Personnel, Engineers, and Quality Group

Communities of Practice (COPs)

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

OSD, Sterile Products, Biotechnology, C&Q, Containment, and Critical Utilities