GAMP Part 2 – The Regulatory Focus on Data Integrity
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.
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.
- 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
Communities of Practice Members that will Benefit
- Good Control Laboratory Practices
- Investigational Products
- Project Management