Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 2: What do we mean by Quality by Design (2020)

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


  1. What is Quality by Design?
    •   What QbD is and what QbD is not?
  2. History of QbD
  3. Quality by Design - The Juran Trilogy
  4. QbD Implementation: Plan, do, check, act
  5. ICH Guidelines - Manufacturing
  6. ICH Guidelines - GCP
  7. Quality by Design - defined
  8. How QbD improves clinical trials
    • QbD Step 1
    • QbD Step 2
    • QbD Step 3
  9. Bringing QbD into an organization
  10. FDA point of view (per J Mulinde)
  11. Cause of errors
  12. Examples of errors
  13. Global attention on quality
  14. Quality focused guidance and activities
  15. International Standards Organization - ISO 8402
  16. QbD Recommendations
  17. Some reasons for poor quality
  18. Some ways to achieve high quality in clinical trials
  19. Pfizer QbD Pilot
  20. Pfizer QbD Pilot: PDCA methodology
  21. Pfizer QbD Pilot: Sample metrics
  22. Pfizer QbD Pilot: Risk assessment framework (site focused)
  23. Myths about quality
  24. Final Thoughts


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


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