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Challenges and Opportunities for Implementation of Quality by Design (QbD)
Tuesday, November 13
2:00 pm – 4:00 pm
Roundtable
ACPE #073-999-07-580-L04
This roundtable will discuss the opportunities and challenges associated with the implementation of Quality by Design. The “lessons learned” from CMC pilot program will also be discussed. For a QbD application it is expected that the sponsor will describe the control strategy, control space and design space. The agreement with FDA from both review and inspection perspective is essential to achieve a successful outcome. The sponsors will need to develop robust quality systems, which support QbD and encourage continuous innovation. It is expected that successful implementation of these approaches will provide the sponsors with some regulatory flexibility.
Moderators
Nirdosh K. Jagota, Ph.D.
Wyeth Pharmaceuticals
Moheb M. Nasr, Ph.D.
U.S. Food and Drug Administration
CMC Pilot Program: What Are The Best Practices for Quality Assessment: FDA Perspective
Chi-wan Chen, Ph.D.
U.S. Food and Drug Administration
CMC Pilot Program: What Are The Best Practices for Quality Assessment: An Industry Perspective
Jeffrey J. Blumenstein, Ph.D.
Pfizer Inc.
Global Regulatory Submissions Based Upon QbD Approach: Challenges and Opportunities
Ferdinando Aspesi, Ph.D.
Wyeth Pharmaceuticals