Quality by Design in Pharmaceutical Development

• • 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 chemical development, 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
  • Criticality: of PP and MA, CPPs and scale dependence
  • Consideration of impurities, ICH M7 and QbD, control strategies, case study
  • Control strategies: different levels, monitoring and control, post-approval changes
  • Chemistry and scale up considerations: process complexity, mixing, mass transfer, heat transfer, modelling
  • Process capability, process analytical technology
  • QbD and continuous processing: FDA perspective, advantages, challenges
  • Quantification of CPPs
  • DoE in QbD: introduction to DoE, where does DoE fit in QbD
  • QbD in API manufacture, case studies
  • QbD in Action: breakout workshop and case studies
  • Initial expectations vs current practices
  • Summary and definitions

• To provide a comprehensive understanding of QbD including current uses and promised use
• To provide a step-by-step process for successful QbD
• To introduce DoE for QbD purposes
• To apply QbD to develop safe and robust processes
• To use a comprehensive manual with examples and case studies to further educate on the QbD process

After completing the course attendees should have:

• A comprehensive understanding of QbD including the process and all associated definitions
• The ability to develop and use Quality Target Product profiles (including identifying CQAs, identifying, prioritising and quantifying process parameters and material attributes)
• An understanding of different risk assessment techniques to determine and manage risk
• Ways to determine and implement control strategies
• The skills required to develop and understand the robustness of processes
• The tools to identify potential mixing and scale up problems
• An understanding of DoE in relation to QbD
• An appreciation of the benefits of continuous manufacturing from a QbD perspective
• An appreciation of QbD in analytical chemistry, formulation, process development and manufacturing
• An appreciation of PAT in QbD

Chemists, engineers, analysts and formulators in pharmaceutical development

Anyone involved with the development of new or existing drug products; changes or improvements to existing or generic drugs are subject to QbD principals.

The course fee includes:

• Link to watch all five live sessions
• Electronic version of the course manual*
• Course certificate

For this on line course, there will be no recordings available and *the e reader manual is NOT printable or downloadable (due to copyright).  If you prefer a hard copy of the manual you will have the opportunity of purchasing a professionally printed hard copy during the booking process.