Course Name: Quality By Design (Qbd) And Process Analytical Technology (Pat) For Pharmaceuticals & Biopharmaceuticals.

This course aims to describe the key concepts that interplay in defining and implementing QbD and PAT towards development and manufacturing of pharmaceutical and biopharmaceutical products. This will be achieved via lectures and presentations of Industrial Case Studies and Participative Discussion and Assignments. Concepts discussed include: Critical Quality Attributes (CQA), Design Space, RiskAssessment, and Process Analytical Technology. The course will be practically oriented with examplesand specific guidance on how to apply these concepts in practice during Product Development and Manufacturing.

Outcomes Of The Workshop

At the completion of this workshop the participant will be able to -:

  • Explain the link between CQAs and Design Space.

  • Describe what would he/she need to do differently in their present job in the QbD paradigm.

  • Explain the role of PAT in QbD paradigm.

  • Discuss the challenges of implementing QbD.

  • Explain the role of Risk Assessment and where to go to find the appropriate tool.

  • Challenges that one is likely to encounter when implementing QbD for commercialization of pharmaceutical products.