Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 5: Integrating QbD into Team Science, and Project Management for Research Success (2020)

In this series, we will discuss the principles of quality by design.

Research & Study Design
Regulatory & Quality Sciences
Allison Zumberge Orechwa, PhD, MBA

Senior Director of Strategy and Innovation

Topics

  1. The need
  2. The USC solution
  3. QbD: A brief history
  4. QbD at USC
  5. QbD resources
  6. Exercise: A case study, factors to consider in selecting critical to quality factor
  7. Team science
  8. Project management essentials
  9. Project planning: Accrual projections


 

Acknowledgement

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu