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.

Theoretical Aspects:

• 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

Practical Exercises:

• 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.
 

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