Quality by Design (QbD) Using JMP^®

Learn how to:

• Implement QbD principles from discovery through product discontinuation.
• Apply statistics to set specifications and validate measurement systems (assays).
• Use risk management tools to identify and prioritize potential critical process parameters.
• Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs).
• Establish your design space.
• Develop a control plan as part of a risk management strategy.
• Ensure that your process is in (statistical) control and capable.

Introduction to Quality by Design (QbD)

• Quality by Design (QbD) principles.
• Product Quality System framework.

Primer on Statistical Analysis

• Basic statistics.
• Hypothesis testing.
• ANOVA and regression.
• Blocking.

Foundational Requirements for QbD Studies

• Setting specifications.
• Measurement Systems Analysis (MSA) for assays.

Introduction to Design of Experiments (DOE)

• Steps to DOE.
• Defining critical-to-quality attributes (CQAs).
• Identifying and prioritizing potential process parameters.

Screening Designs

• Factorial designs.
• Fractional factorial designs.
• D-optimal designs.

Response Surface Designs

• Addition of center points.
• Face-centered CCD.
• Box-Behnken Design.
• I-optimal designs.

Specialized Designs

• Definitive screening designs.
• A-optimal designs.

Using Systematic Understanding from QbD Studies

• Presenting results.
• Developing a control plan as part of a risk management strategy.
• Process control and capability.

Advanced DOE Methodologies (Optional)

• Split-plot designs.
• Robust parameter design.
• Supersaturated designs.
• Constrained designs.
• Mixture designs.