F8 - 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.

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.

Topics included:

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 modelling: 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 reqiured for this seminar

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