Quality by Design
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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.