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