QbD Mastery: Product & Process Optimization through DoE
Integrating FDA regulatory perspectives, statistical foundations, and practical applications for robust biopharma and manufacturing innovation.
Understand the history, goals, and relevance of FDA’s QbD initiative and key ICH guidelines (Q8, Q9, Q10).
Learning Objectives
- Grasp the history and goals of FDA's QbD initiative.
- Understand ICH Q8, Q9, and Q10 guidelines.
- Review case studies of QbD in industry practice.
Test Your Knowledge
Resources
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