Continuous Processing and Process Control: Improving Manufacturing Through Innovation
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.
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.
- 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
- Service Providers
Communities of Practice Members that will Benefit
- Good Control Laboratory Practices
- Investigational Products
- Operations Management
- Process Analytical Technology