What you’ll learn
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Introduction: Why QbD, what is QbD? FDA objectives, the QbD approach
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The QbD process: QTPP, assessing risk, working through unit operations to determine CPPs and CMAs
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QbD in development of formulation, method development, and manufacturing
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Drug properties: setting your QTPP, risk assessment, risk management, risk assessment questions
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Identifying CQAs: drug product QAs, drug substance QAs, raw material QAs
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Determining CPPs and CMAs
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Product or Process design
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Control strategies: different levels, monitoring and control, post-approval changes
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QbD and continuous processing: FDA perspective, advantages, challenges
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DoE in QbD: introduction to DoE, where does DoE fit in QbD
