Oral Solid Dosage Processing and Containment
(Track 2)

This session will provide input on Granulation and Compression processes and methods to improve your processes efficiency. FDA Regulatory issues around OSD processing will be presented. Fred Rowley, a noted authority on OSD manufacturing who has recently completed similar training for the FDA on this topic will present on the Compression process. In addition, the topics of equipment set up and lessons learned for successful Granulation will also be presented.

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

• Understand the two components of OSD processing methodology, Granulation and Compression
• Process potent and highly hazardous products in a contained manner during these same process steps
• Assure product quality levels while eliminating the risk of cross contamination
• Evaluate the risks associated with various strategies
• Gain benefits to the life cycle cost of operations including how reduced energy use can benefit the site's profit and loss (P&L) statement

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

• EVENT HANDOUTS

Host Sponsor

Silver Sponsor

Reception Sponsor