- What is Quality by Design?
- What QbD is and what QbD is not?
- History of QbD
- Quality by Design - The Juran Trilogy
- QbD Implementation: Plan, do, check, act
- ICH Guidelines - Manufacturing
- ICH Guidelines - GCP
- Quality by Design - defined
- How QbD improves clinical trials
- QbD Step 1
- QbD Step 2
- QbD Step 3
- Bringing QbD into an organization
- FDA point of view (per J Mulinde)
- Cause of errors
- Examples of errors
- Global attention on quality
- Quality focused guidance and activities
- International Standards Organization - ISO 8402
- QbD Recommendations
- Some reasons for poor quality
- Some ways to achieve high quality in clinical trials
- Pfizer QbD Pilot
- Pfizer QbD Pilot: PDCA methodology
- Pfizer QbD Pilot: Sample metrics
- Pfizer QbD Pilot: Risk assessment framework (site focused)
- Myths about quality
- Final Thoughts
Nancy Pire-Smerkanich, DRSc, MS
Associate Director, Regulatory Knowledge and Support