Bridging the Compliance and Operational Excellence Gap by means of People, Technology and Science

Session 409
Manufacturing Operations

How do we truly enable our organization to use all of these concepts and tools synergistically to realize their value? What are the real requirements for our technology platform to enable a fundamental science and risk-based approach for understanding and continually demonstrating control of our processes? And finally how do you start this potentially long journey and how can these gaps be bridged in an effective and timely manner.

Session Description

Find the best practices to drive performance of manufacturing operations using methods such as QbD and Operational Excellence. This session will follow a comprehensive, modern approach to managing and assuring quality including technology, software and information management solutions for Continuous Process Validation that ensures compliance with evolving regulatory expectations.

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

Assess existing technology platform and manufacturing system ability to provide the information and functionality required to enable Operational Excellence and QbD
Understand the concepts of Operational Excellence, QbD and Risk-Based approaches and how they relate to each other

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

Communities of Practice Members that will Benefit

C&Q
GAMP^®
Operations Management
Process Analytical Technology

More information on ISPE's Communities of Practice