Continuous Processing and Process Control: Improving Manufacturing Through Innovation

Session 505
Manufacturing Operations Track

Many companies have presented in recent years regarding the use of continuous processing as an alternative to batch-based manufacturing. Existing GMP guidance is expected to be broadly applicable to continuous processing, but most quality systems have been developed to support batch-style operations.

Session Description

Join a forum for best practices and regulatory feedback regarding the application of GMP concepts to continuous processing. Case studies will be based on a continuous process facility consisting of two dosing stations, a continuous mixer, and a tablet press equipped with NIR technology providing 100% inspection for process control.

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

Understand areas of potential GMP impact due to migration from batch to continuous processing.
Assess benefits and challenges of batch vs. continuous processing and apply the concepts presented.
Understand the advantage of 100% inspection.
Know about new integration technologies - get a detailed understanding of rapid NIR spectroscopic tools.

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

API
Biotechnology
C&Q
GAMP
Good Control Laboratory Practices
Investigational Products
Operations Management
Process Analytical Technology

More information on ISPE's Communities of Practice