Quality by Design (Q-b-D) for Biopharmaceuticals

QBD class

Virtual delivery available!

Email  Catherine Bouthillier

UPCOMING PROGRAM DATES: In-person TBD, contact Catherine Bouthillier to discuss virtual delivery!

Application of Quality by Design (Q-b-D) methodology for product commercialization is increasingly becoming the standard business practice at Pharma and Biotech companies. It is also much sought after by US and EU regulators as an approach presented in regulatory dossier to demonstrate that product will be safe and effective consistently over its lifecycle. While the concept of Quality by Design is universal and commonplace in many sectors, its application in Biotech industry for product commercialization is relatively new and “purpose-built” to suit the nuances of the products and processes.

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A 2-hour online lecture must be viewed anytime prior to the start of the program.


This course will take the students through the journey of using a combination of classroom presentations and case studies such that they will be “ready” to participate in Q-b-D related activities related to a Biotech product.

  • Introduction to Q-b-D principles- A science- and risk-based approach
  • Product understanding – Critical Quality Attributes (CQAs) – patient safety and needs
  • Process understanding
  • Development of Process and Analytical Control Strategy
  • Statistical Methods and data analysis
  • Quality Risk Management (QRM)
  • Design of Experiments (DOE)
  • Process Optimization & Response Surface Methodology– Ranges, Design Space,
  • Root causes analysis – FMEA, risk ranking and apply FMEA to Control Strategy selection
  • Technology Transfer to manufacturing and Continuous Process Verification Strategy
  • CASE Studies