Applying Design Control & Control Strategy to Support the Development of Combination Drug Products

18 September 2023 14:20 - 14:50

  • Understanding design control expectations
  • Establishing a control strategy to deliver safe and efficacious products
  • Understanding the difference between CQAs and EPRs
  • Defining your device engineering and testing parameters to ensure quality and compliance

Ajit D'Souza, Senior Director, Drug (Combination) Product Development & Manufacturing, Kiniksa Pharmaceuticals