Qbd: Quality by Design in Pharmaceutical Product Development
QbD, QTPP, CQA, CPP, CMA, Risk Assessment, Design Space, Control Strategy, Continuous Product Quality Improvement,
4.10 (111 reviews)
2 434
students
2.5 hours
content
Feb 2022
last update
$34.99
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What you will 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
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Related Topics
4147852
udemy ID
26/06/2021
course created date
19/09/2021
course indexed date
Angelcrc Seven
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