Moving to Agile in an FDA Regulated Environment
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.
The session will be delivered by an employee from Company X, and business executives from a consulting company that assisted Company X with their agile adoption. The session will focus on “real world” project examples based on years of practical experience.
The session will involve a presentation followed by Q&A.
- How to achieve the benefits of agile while delivering the artifacts that are required for FDA approval
- How to use traceability, design control and change control to increase product quality
- What’s different about the requirements process in these projects?
- How much can agile really reduce your product development time in this environment?
- Does the FDA really care if you use agile or waterfall?
- How to take what used to be independent development and QA groups and integrate them into a self-directed agile team
- How to deal with the executive management that is used to a plan driven, “tell me everything before we start” approach
- Appreciation for the dramatic culture shift that needs to take place, and is it best when driven from the top, bottom, or both