Quality by Design (QbD) Using JMP® Software

This course focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Analyses in this course use the point-and-click interface of JMP Software by SAS.

Voraussetzungen
Before attending this course you attend the course „JMP Software: statistische Datenanalyse" (JDEX10). It is helpful if you have also attended the course „JMP Software: Varianzanalyse und Regression" (JANR10).

Zielgruppe
Scientists and engineers who need to integrate Quality-by-Design (QbD) principles into their pharmaceutical development and quality systems

Module
JMP Software

Kursinhalte

• Primer on Statistical Analysis
  • basic statistics
  • hypothesis testing
  • ANOVA and regression
  • blocking
• Introduction to Quality by Design (QbD)
  • Quality by Design (QbD) principles
  • Product Quality System framework
• 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 - Identifying Critical Process Parameters
  • factorial designs
  • fractional factorial designs
  • D-optimal designs
• Response Surface Designs - Develop Functional Relationships and Establish Design Space
  • Central Composite Designs (CCDs)
  • Box-Behnken designs
  • I-optimal designs
• Utilizing 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

Referent
This course will be presented by Heath Rushing, principal consultant and co-founder, Adsurgo LLC.

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