Track 1: Manufacturing

Worried about bringing in your plant automation project on time and on budget?

Description

Automation is a key element of biopharmaceutical manufacturing. Yet, for many companies, the management of a an automation project can be extremely challenging. Achieving the seemingly conflicting goals of cost effectiveness and full compliance causes problems. In this highly interactive track, be part of the solution. Participate in instructor-led workshops to understand how validation has evolved and how to achieve full compliance. Help companies and the regulators bring cost effective automation projects to market faster.

How You Will Benefit

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

Understand the interrelationship between Commissioning and Qualification and Computerized Systems Validation from a Project Standpoint

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

Who Should Attend

Project Managers
Manufacturers
GAMP^® COP
C&Q COP