CARS™ for Teams (Certified Agile Regulatory Specialist) Class

Agile methods don’t conflict with FDA regulations.

They often conflict with the way organizations interpret and implement those regulations.

The result?

• Teams delay documentation until the end.
• Quality and Engineering speak different languages.
• Releases become stressful.
• Audits feel risky.

This class shows how to work differently without compromising compliance.

By the end of the session you’ll be able to:

• Explain how Agile practices satisfy Design Controls
• Connect Agile artifacts and events to regulatory expectations
• Use Definition of Done as a compliance mechanism
• Treat backlog management as legitimate change control
• Reduce documentation bottlenecks without increasing audit risk
• Use language that resonates with Quality and auditors
• Distinguish regulatory requirements from organizational habits

Topics Include

• Design Controls in an Iterative Model
• “Any Sequence Will Do” (in practice)
• Definition of Done as a Control Mechanism
• Documentation Strategy
• Change Management Through Backlog Control
• Audit Scenarios and Real-World Questions

This class is ideal for:

• Software Engineers
• Test Engineers
• Quality Engineers
• Design Assurance Professionals
• Product Owners
• Scrum Masters
• Systems Engineers
• Engineering Managers
• Program and Product Managers

About the Instructor, Jeff Lee

Jeff is a Partner at agilityIRL, where he focuses on coaching at the team and leadership levels as well as training individuals and organizations. He takes pride in his ability to help teams reach their full potential while helping the organization support team success.

Jeff’s extensive consulting experience has exposed him to a wide variety organizations and industries with uniquely different paths to success. In the earlier stages of his career, Jeff held development, business analysis and testing roles before moving into project management where he spent 10 years as a PMP-certified project manager, managing large programs for a variety of Fortune 500 clients.

This wide-ranging background led Jeff to eventually focus on Agile development, working as a Scrum Master and Program Manager in Agile environments. He has worked on and with Agile teams in a variety of industries and environments where he’s seen Agile work in industries as diverse as medical device manufacturing and online retail.

As an Agile coach and trainer, Jeff is able to leverage his unique experience to help organizations gain a clearer picture of their full operating system in order to identify their true constraints and opportunities and unlock their full potential through the application of Agile.

Jeff’s Agile certification credentials include: PST, PSM-III, CSPO, CLP, SPC, CARS and PMP.