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
Deal Score0
External links may contain affiliate links, meaning we get a commission if you decide to make a purchase