PQLI^®/PAT - Moving Beyond ICH Q8, 9, and 10 Concepts: Biotech QbD Realization Case Studies Leveraging PAT
(Session 405)

Tuesday 8 November 14:15 – 17.15

ISPE CEUs: 0.25

There is a need to provide a range of tools for developing products and their manufacturing processes using the enhanced, quality by design (QBD) approach described in ICH guidelines, Q8(R2), Q9, and Q10. Presentations in this session will feature the ISPE Product Quality Lifecycle Implementation^® (PQLI^®) approach to product design, development, and realization in a science- and risk-based fashion. An approach to needed guidance will be described, a small molecule illustrated example will be provided, as well as interactive discussion on the topics of (1) critical quality attributes and critical process parameters, (2) design space, and (3) control strategy. Active attendee participation/discussion is encouraged in this session and ideas generated may be included in the upcoming development of ISPE PQLI Guidance Documents.

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

How You Will Benefit

• Understand the PQLI approach to implementation of ICH guidelines
• Contribute to an ongoing discussion to identify where tools and processes are needed to help industry with effective implementation
• Explain what is meant by critical quality attributes and process parameters
• Discuss design space
• Examine control strategy

Who Should Attend

Any professional involved in product design, product realization, process and engineering design scientists, regulatory professionals, QA/QC/Compliance, validation, technology transfer and manufacturing professionals, and anyone working with small or large molecules, and in a small, medium, or large company, innovator, OTC or generic and at any level

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

API, Operations Management, Oral Solid Dosage, PAT, and Product Process Development