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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Seminar number: F8 Design of Experiments,
Quality by Design: MODDE®

Course language:

English

Course date:

currently in planning

Course duration:

3 days

Seminar schedule:

Start 1st day: 9:00 am / End 3rd day: 5:00 pm

Instructor:

Course fee:

Seminar Booking

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