This session will focus on the unique challenges companies face when using agile on projects that involve FDA governance: large company conservative culture, regulatory documentation, requirements tracing, and a bias towards waterfall development.

Skeptics argue that agile is best suited to small- and medium-sized companies and wrongly perceive agile as a limited, negating its use in the highly regulated corporate world.

In reality we will show you how we’ve successfully implemented agile in large sized companies operating in a highly regulated world.

Traditional thinking holds that the more critical the application, the more tightly its development must be planned, staged, and controlled.