Philadelphia, PA – Quality by Design


The practical application of QbD within the pharmaceutical space is a classic application of Design for Six Sigma principles and tools.  The overall framework and tools used within QbD, e.g., risk-based quality management, statistical design of experiments (DoE), robust process design, and real-time process control through process analytical technology (PAT) as applied for pharmaceutical QbD efforts are areas of significant expertise for our instructors. The instructors will provide insight, instruction and application guidance for the QbD process and the tools required for its successful execution.  Furthermore, they will also provide relevant insights and experiences they have gained through years of real-world QbD situations, as well as providing helpful context regard the current QbD landscape as it relates to current industry practices and regulatory agency interactions.

SKU: QBDPH Category:

Product Description

Philadelphia, PA Quality by Design


NOTE: One-day course participants will obtain a conceptual understanding, while five-day course participants will obtain more detailed and advanced understanding through a combination of hands-on exercises and analysis of various case studies.

One-Day “QbD Overview” Course:

  • Background and drivers for Pharma QbD
  • QbD guidance review (ICH Q8/Q9/Q10/Q11)
  • QbD development process and flow/logic
  • Introduction and overview of QbD tools
    • Risk management
    • Design of Experiments
    • Design Space
    • Control Strategies
  • Current industry and regulatory landscape, and application challenges for QbD

Five-Day Course: One-Day “QbD Overview” PLUS:

  • Focused hands-on DoE training and practice
  • Full vs fractional factorials
  • Optimization and response surfaces
  • Transfer functions
  • Detailed training on QbD concepts & tools, e.g.
  • QTPP and CQAs/CMAs/CPPs
  • Risk management tools and practices
  • Design space: development, verification and scale-up
  • Control strategies, process robustness and proactive management of process variation
  • Round-table exercises for problem-solving your QbD implementation challenges

Objectives/Learning Outcomes

  • Understanding the origins and need for QbD for pharmaceutical products, and the objectives for current QbD practices
  • Understanding the overall logic and flow of the QbD development process, including the use and application of the various tools applied:
  • Risk-based quality management
  • Development and use of Quality Target Product Profiles (QTPPs), and definition and verification of Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs)
  • Facets of statistical design of experiments (DOEs), e.g., screening designs, response surfaces and optimization, transfer functions
  • Design Space and its application: process control, lifecycle management, understanding design space limits/“edges”
  • Development and optimization of process control strategies, including real-time release testing.
  • The ability for attendees to apply these QbD tools and principles to their own problems, facilitated through round-table discussion of challenges faced by attendees