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

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 | atambe@usc.edu