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.

Topics

  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

Acknowledgement

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

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

Instructors

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.