Process Validation (Track 3)

The workshop will include leveraging PV stage 1 (development) information, determining process validation acceptance criteria, sampling plans determining the number of batches for PV stage 2, determining an appropriate level of heightened sampling and testing post PV stage 2 and managing the PV stage 3 plan.

Attendees will have the chance to discuss, benchmark, and practice application of practical approaches for satisfying lifecycle Process Validation expectations. You will also be able to hear regulator reactions to approaches, including strengths and opportunities for improvement, over the course of the workshop session.

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

• Gain clarity around the content of the FDA PV Guidance concepts
• Understand approaches and thinking from industry and regulatory leaders
• Gain insight into the practical impacts into the lifecycle approach to PV
• Determine process validation acceptance criteria

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