Dr. Victor Awafo is a Deputy Director, Manufacturing Technology, Sanofi Pasteur, Canada. He is a trained Applied Microbiologist and a Certified Lean Six Sigma Black Belt. He has been in the Bio-Pharmaceutical industry for 13 years. He has held positions of increased responsibility in Manufacturing Technology in Validation and Process Improvement activities. He was a member of the Vaccine Consortium that developed the A-VAX case study that could be used to illustrate how (and if) QbD could be applied to vaccine development.