Track 2: Laboratory

There are common threads in many compliance problems experienced in the laboratory. Do you know what they are?

Description

Validation of a computerized system is just as critical in a laboratory as it is in Manufacturing. Gain a better understanding of what the Regulatory Agencies are looking for in relation to Quality Systems. Learn through case studies and get immediate feedback from subject-matter experts and FDA representatives on how to take a risk-based approach to the validation of laboratory computerized systems with GAMP^®5.

How You Will Benefit

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

• Apply new risk-based concepts related to laboratory systems validation as presented in the new GAMP Good Practice Guide

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

• GAMP COPs
• Laboratory Managers
• Scientists
• Quality Assurance Professionals