Education Sessions

PAT Implementation Tools and Methods (101)

26 October 13.00-17.00

(PDF Current as of 9 October 2008)

This session will address questions, concerns and successes regarding PAT implementation including the use of thought-provoking case studies and discussion, the lifecycle of a typical Quality by Design project. Additional topics will likely include identification of potential projects, conceptual design, data monitoring, applying data to process improvement, transitioning to validated tools and methods, commissioning and qualification. Lessons learned and discussions will play a major role.

Product Quality Lifecycle Implementation (PQLI) and QbD concepts are being defined and PAT tools are being increasingly used. However, there are still more questions than answers on how to successfully implement these initiatives. The groundwork has now been laid. The intent of this session is not for any one person to teach the “answer,” but to encourage a discussion to find best practices.

How You Will Benefit

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

Research and develop process data gathering projects using PAT
Determine a path forward for utilization of process data for process improvement
Understand and determine the application of process improvement tools and methods in a validated environment

Who Should Attend

Process development, validation, quality, manufacturing, automation and engineering personnel, and everyone interested in Product Quality Lifecycle Implementation (PQLI)

ISPE Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Biotechnology (Biotech), Commissioning and Qualification (C&Q), Process Analytical Technology (PAT), and Process/ Product Development (PPD)

Session Leader

Nathan Temple, Project Manager, Commissioning Agents Inc, USA

Session Speakers

Mette Bryder, Senior Project Manager, H. Lundbeck A/S, Denmark
John Levins, Senior Director, Pfizer, USA
Line Lundsberg-Nielsen, Senior Consultant, NNE Pharmaplan, United Kingdom