Building an Autoinjector Development and Supply Ecosystem

18 September 2023 11:40 - 12:10

  • QMS Requirements – FDA 21 CFR Part 4, Design Control vs Change Control
  • Device Assembly and Testing Considerations
  • Platform technologies vs customizations vs bespoke designs
  • Development of Device Packaging, Labelling, Instructions and Training Material
  • Role of Human Factors Engineering
Developing, launching and supporting a drug-delivery autoinjector requires specific systems, procedures, capabilities and skills.

Mark Howansky, Vice-President, Device Development and Commercialization, Viridian Therapeutics