Design of Experiments, Quality by Design: MODDE®
Who should attend: Group Manager, Laboratory Head, Plant managers, Assistants in Research and Development, Production, Analytics, Drug Delivery and Approval in Pharmaceutical Industry, Biochemistry and Fine Chemistry.
Topics included: Acquisition of practical and theoretical skills for applying Design of Experiments (DoE) in Pharmaceutical development toward fulfilling requirements of Quality by Design (QbD) – ICH Q8/Q11 – and toward optimization of processes.
- Principles of DoE: the DoE-cycle from the Design to the Design Space
- Principles of QbD – requirements of ICH Q8/Q11
- Design: Full and Reduced factorial designs for Screening
- Designs for quadratic modeling: CCD, Box-Behnken, D-optimal Designs
- Analysis: Effect calculation, determination of model coefficients using regression analysis
- Diagnostics and Validation: Residual analysis, variance analysis (ANOVA)
- Quality by Design: Visualization, Optimization, Prediction, Multi-Response Optimization, Sweet-Spot Analysis, Design Space
- Model usage for prediction, visualization, optimization
- Exercises and practical real life examples such as:
- Fractional Factorial for a Screening (Host Cell Protein Removal)
- D-optimal for Product Optimization (Peptid Spaltung)
- Central Composite for Process Optimization (Host Cell Protein Removal)
- Screening for A-QbD robustness study (HPLC-analytics)
There are no special classes required for this seminar.
Seminar number: F8 Design of Experiments,
Quality by Design: MODDE®
currently in planning
Start 1st day: 9:00 am / End 3rd day: 5:00 pm