What is Quality By Design (QbD)… and why take a course on QbD from us? A long-standing axiom states that quality must not be “inspected in”, but rather “built in” if products and services are to have long-term success. Joseph Juran’s influential work, Juran On Quality By Design: The New Steps For Planning Quality Into Goods And Services (1992) exhaustively presents numerous cases studies from broad-ranging industries that show the vast majority of product and service failures are the result of poor design. At the turn of the millennium pharmaceutical products were defined largely by their manufacturing processes that were poorly understood, which produced products that were understood even less. Quality was determined almost entirely by post-process inspection, with virtually no foundation to build upon for corrective actions or continuous improvement. This state led to major global regulatory authorities for pharmaceuticals driving QbD initiatives over the last ten years that have become initiatives within the industry itself, where QbD practice has increasingly become Best Practice within many pharmaceutical companies.
The benefits of a Quality by Design approach to pharmaceutical products includes but is not limited to:
Greater end-to-end control over production that results in dramatically improved predictability towards product safety and efficacy
Streamlined product lifecycle management and associated interactions with regulatory authorities, from initial product launch to discontinuation
A substantial foundation for continuous process improvement, coupled with more rigorous and efficient corrective actions
Significantly greater control over inspections and audits, with findings that are lower in impact and fewer in number
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.
Agenda Five-Day 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
Design of Experiments
Current industry and regulatory landscape, and application challenges for QbD
Focused hands-on DoE training and practice
Full vs fractional factorials
Optimization and response surfaces
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
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
Quality by Design Full Course Dates
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