Qbd: Quality by Design in Pharmaceutical Product Development

Qbd: Quality by Design in Pharmaceutical Product Development

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?

  • To Access "Qbd: Quality by Design in Pharmaceutical Product Development" Click on Enroll Now button at end of the post. It will redirect you to Udemy Course Page and then you can start the enrollment process.
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