Regulatory and Industry Perspective of Quality by Design (QbD)

Session 303
Regulatory Track

The concept of Quality by Design (QbD) for pharmaceutical industry was born in 2004 with the US FDA's 21st century initiative. However, the adoption of QbD by pharmaceutical industry is quite slow. The factors slowing the adoption of QbD have been well documented. In a study commissioned by US FDA in 2009, McKinsey & Co. was engaged to work with CDER to summarize the challenges to broader adoption of QbD across the industry. One challenge that was raised by the majority of companies was a need for more tangible guidance or “information…about how to actually do it on the ground.” One interviewee commented that “we understand what you are asking for broadly, but there are hundreds of variables – there has to be an end in mind – a tangible one we can deliver on.” Companies are seeking a set of ground-rules from the FDA around such things as acceptable methods, criteria to select and deselect critical quality attributes, standards to judge adequacy of controls, and criteria for analytical method substitution.

Two US FDA speakers (Dr. Christine Moore and Dr. Lawrence Yu), three industry speakers (Dr. Christopher Sinko from Bristol-Myers Squibb; Dr. Paul Stott from AstraZeneca and Dr. Yatindra Joshi from Teva Pharmaceuticals) and Dr. Greg Amidon from University of Michigan will be invited to give presentation on the opportunity, challenges and future direction for QbD implementation with emphasize on detail expectation from regulatory agency and industry perspective.

Session Description

Regulatory, industry and academia speakers will be invited to give presentation on Quality by Design (QbD) implementation. The main focus of this symposium is to discuss the practical experience and detail expectations and approaches from regulatory agency and industry perspective. The opportunity, challenges and future direction for QbD implementation will be also discussed.

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

Understand US FDA latest thinking on implementation of QbD.
Understand the pharmaceutical lifecycle from QbD in development to product realization.
Understand practical examples of implementation of QbD in product development.

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

Who Should Attend

Manufacturing/Operations
Service Provider
Regulator
Suppliers

Communities of Practice Members that will Benefit

API
Biotechnology
PAT
Product Process Development
Project Management

More information on ISPE's Communities of Practice