Qbd: Quality by Design in Pharmaceutical Product Development
QbD, QTPP, CQA, CPP, CMA, Risk Assessment, Design Space, Control Strategy, Continuous Product Quality Improvement,
4.09 (110 reviews)
2,428
students
2.5 hours
content
Feb 2022
last update
$34.99
regular price
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
6/26/2021
course created date
9/19/2021
course indexed date
Angelcrc Seven
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