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.


  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



Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.