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.

Research & Study Design
Regulatory & Quality Sciences

Topics

  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

Acknowledgement

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