Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 1: Introduction (2020)

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

Regulatory Science
Quality by Design
Quality Science
Eunjoo Pacifici, PharmD, PhD

Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science


  1. Symposium Log-In
  2. SC CTSI Clinical Research Support (CRS)
  3. Monitoring Module
  4. Establishing a Monitoring Pool at USC
  5. USC Graduate & Certificate Programs in Regulatory Science
  6. Critical topics related to the principles of Quality by Design
  7. List of symposiums and recordings
  8. Suggestions for the next symposium topic
  9. Quiz Time!
  • “Quality” in clinical trials is defined as:
  • What industry first originated the idea of quality by design (QbD)?
  • Why is quality by design important?
  • Three key principles of quality science include determination of quality of the end product, culture of productivity, and focus on consumer feedback. True or False?
  • Which of the following is not a QbD recommendation from CTTI?
  • What is an example of a factor critical to quality?
  • Understanding what is critical to quality allows for tailoring the protocol design to eliminate unnecessary complexity, avoid errors in conduct, and devise a focused monitoring and auditing plan. True or False?
  • What were some concerns that led to QbD application to clinical trials?
  • What are some barriers to QbD implementation?
  • Determine if the QbD was applied in the pictorial experiment?


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.