GAMP Part 2 – The Regulatory Focus on Data Integrity

Session 305
Manufacturing Operations Track

Pharmaceutical managers rely on their laboratories for critical analyses; purity, identity, stability & quality to name a few. With an increased regulatory focus on laboratory systems, the integrity of these analyses is a major business concern, yet many in management may not be aware of the current applicable regulatory requirements or how to identify and assess risk factors.

Session Description

Pharmaceutical managers will engage in discussions to ensure that their organizations are prepared for increased regulatory focus on laboratory systems. The session will utilize chromatography systems as an example due to their role in business-critical analyses. The second part of this session will explore the breakdown of the clinical development process and how the principles of GAMP 5 can be applied to associated data (e.g., study data) using a risk based approach.

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

Understand and apply a data lifecycle approach to ensure data integrity.
Understand how risk factors can be mitigated in business-critical systems and convey the activities essential to ensuring data integrity.
Engage in discussions to ensure organizations are prepared for the increased regulatory focus on laboratory systems.
Identify and assess risk factors Understand the breakdown of the clinical development process and realize how the principles of GAMP 5 can be applied to associated data.
Differentiate how clinical processes and their generated data differs from traditional marketed products.
Gain a stronger understanding of computer systems validation within R&D and the clinical environment.

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

Manufacturing / Operations
Service Providers
Suppliers
Regulators

Communities of Practice Members that will Benefit

Biotechnology
C&Q
GAMP
Good Control Laboratory Practices
Investigational Products
PQLI
Project Management

More information on ISPE's Communities of Practice