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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