What to Expect From Our CARS™ Education & Certification

Our Certified Agile Regulatory Specialist or CARS™ program is designed to help leaders, Quality Assurance and Compliance personnel, program managers and development team leaders (definers, designers, developers and testers) employ an Agile development framework within their FDA-regulated and QMS-governed organizations.

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Why Choose CARS™ Certification?

Although Agile methods don’t conflict with FDA regulations, they do often conflict with a company’s Quality Management System (QMS). The QMS procedures must be adapted for Agile methods. Likewise, your Agile implementation must account for compliance to regulations.

After participating in this program, you’ll be able to apply Agile methods in ways that unleash the benefits of Agile while satisfying FDA regulations and regulatory expectations. You’ll also understand the intent of these regulations so you can satisfy them in a pragmatic way.

CARS™: A Complete 2-Day Certification Program

Our CARS™ program is a 2-day class, offered both publicly and privately, where you’ll learn the concepts, rules, methods, and tools for incorporating Agile. Once you fully complete the 2-day program by showing up and participating, you’ll be eligible to take the exam to earn your CARS™ certification.

Since you’ll be spending two days with the agilityIRL team, breakfast, lunch, and an afternoon snack will be provided, as well as refreshments throughout the day. There’s no need to bring anything with you; we have all the materials you’ll need.

What Does the 2-Day Program Look Like?

The program includes everything you need to know to become a Certified Agile Regulatory Specialist™ and begin to employ Agile within your organization. The course outline includes:

  • The Rules of the Game: Overview of Medical Device Regulations and Standards
  • Agile Foundations for Design Control
  • Your System: Tailoring Your Process and Agile Practices to Match the System/Product You Develop
  • Aligning Agile With the Regulations and Standards
  • Change Management
  • Definition of Done
  • Any Sequence Will Do
  • Roles
  • Requirements & Backlogs
  • Aligning With a Linear Business Process

Participant Prerequisites

To participate in CARS™ certification, you should possess a high level of proficiency with your organization’s chosen Agile framework (Scrum, SAFe, etc.). You should also be familiar with your company’s QMS.

Read this post to learn more about our CARS™ training

Register for CARS™ Certification Today

To learn how to employ Agile within your FDA-regulated and QMS-governed organization, register today for the January 27-28 CARS™ certification course.