Quality by Design (Q-b-D) for Biopharmaceuticals - WPI Biomanufacturing Education and Training Center

Tuesday, April 14, 2020 to Thursday, April 16, 2020
8:30 am to 4:00 pm
WPI Seaport
303 Congress St.
Boston, MA 02210
United States

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.


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


Who Should Attend

This 3 day course containing workshops, case studies and Q&A sessions is intended for scientists and engineers who are new to Quality-by-Design and/or need an update in their knowledge of the subject. The course is designed and delivered by a leading industry expert who is engaged on a daily basis with all aspects of Q-b-D, from late phase process design, characterization and Tech Transfer to biomanufacturing, validation and regulatory aspects.

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