Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 4: Developing QbD Tools for Clinical Researchers (2020)

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


  1. Background
  2. Challenge: Crisis of trust in clinical research
  3. Solution: Quality by Design
  4. Critical to Quality (CTQ): Categories
  5. QbD an imperative
  6. QbD adoption: Academic health centers
  7. QbD at the local level: UC Irvine QbD workshop
  8. QbD at local level: Implementation of QbD at UC Irvine
  9. QbD at national level: Bigger picture for QbD implementation
  10. Bigger picture for QbD implementation


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.