Evolving FDA Quality Assessment for Small Molecule Human Drug Products

Duration - 47 Minutes

Price - INR-2000 / USD-70

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About the course

Overview of the evolution of the FDA’s quality assessment for small molecule human drugs
QbD, QbR, Integrated Quality Assessment, lifecycle knowledge approach, aligned teams for experts and
Knowledge-aided Assessment and Structured Application (KASA)
Journey in quality assessment and FDA current effort in modernizing quality assessment practice

Speaker Profile

Dr. Geoffrey Wu

Associate Director for Science and Communication, Office of Lifecycle Drug Products, OPQ, CDER
US Food and Drug Administration

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