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Science & Regulation of QbD
Wednesday, November 14
2:00 pm – 4:00 pm
Roundtable
ACPE #073-999-07-566-L04
The FDA’s PAT Initiative and the PAT Guidance provide unprecedented opportunity for pharmaceutical scientists and engineers to play a key role of shifting the pharmaceutical quality paradigm towards the desired state of Quality-by-Design (QbD). Although FDA CDER remains committed to the goals of FDA’s Pharmaceutical Quality Initiative for the 21st Century, there seems to be a lack of real world case study to (1) characterize the scientific and risk-based merits which have been emphasized in the PAT Guidance; and (2) reflect its relationship to the concept of Quality by Design. The invited speakers for this symposium will discuss and provide an update on the topics of (1) Application of PAT tools, risk analysis methodology, and QbD principles for monitoring, understanding, optimizing, and controlling pharmaceutical unit operations for both drug substance and drug product; (2) the relationship between PAT, Risk Analysis, and QbD; (3) challenges and opportunities for pharmaceutical scientists and engineers during implementing PAT in the pharmaceutical industry.
Moderators
Mansoor A. Khan, R.Ph., Ph.D.
U.S. Food and Drug Administration
Huiquan Wu, Ph.D.
U.S. Food and Drug Administration
QbD in API – Examples in Reaction and Crystallization Process Development
San Kiang, Ph.D.
Bristol-Myers Squibb Company
QbD from Development to Manufacturing
Yatindra Joshi, Ph.D.
Novartis Pharmaceuticals
Question-based Review: A New Quality Assessment System
Lawrence Yu, Ph.D.
U.S. Food and Drug Administration