Implementing Agile in an FDA-Regulated Environment 2017

Topics

• Understanding the REAL regulatory requirements
• Countering the village rumors
• Fitting together hardware and software development, and being Agile in both
• Agile is a mindset, not a canned method
• Bringing everyone on board, not just software
• Applying Impact Mapping and Story Mapping practices to chart the way
• Metrics - how to use them and what to avoid
• Applying Agile to larger scale organizations / projects

Who should Attend

• Functional Managers - Software, Test, Hardware
• Regulatory Specialists
• Project Managers (especially for cross-functional teams)
• Other Development Specialists (mechanical, engineering, other)
• Business Analysts
• Software Developers
• Product Managers
• Requirements Analysts
• Portfolio Managers