agilityIRL has distinctive competency in the life science sector and the special subtleties and nuances of operating in an environment regulated by the Food and Drug Administration (FDA). Our new Certified Agile Regulatory Specialist™ (CARS™), program is for those employing Agile in an FDA regulated and company Quality Management System (QMS) governed environment.
CARS™ has been designed, developed and is presented in collaboration by agilityIRL and Agile Quality Systems—people who have not only made Agile work themselves in a real life, but were pioneers in doing so and were part of the industry team that crafted the FDA endorsed ground rules.
CARS™ is Agile-driven, but reality based. It’s design and development flows from not only our collective decades of personal experience with Agile in medical device product development, but also from the personal participation of our lead CARS™ instructor, Kelly Weyrauch of Agile Quality Systems, on the industry team that authored, AAMI TIR45: 2012—Guidance on the use of AGILE practices in the development of medical device software. In other words, CARS™ has been developed and is presented by a team that includes people who actually “wrote the book”.
CARS™ is a 2-day class that will teach field-proven concepts, rules, recommendations, methods, and tools for incorporating Agile in an FDA regulated and QMS governed environment. The class is followed by an exam. Participants successfully participating in and completing the class, and passing the certification exam, will earn their CARS™ certification.
We offer CARS™ education and certification in both public and private settings. Private classes may be arranged by contacting us.
In addition to our CARS™ education and certification program, we also offer the coaching and consulting services to assist Agile adopters successfully make the transition from concept and theory to practical application with all of the pragmatic issues it will entail And, in keeping with our “Agile-Driven and Reality-Based” expertise, our CARS™ consulting is provided for people operating under FDA regulation and QMS governance by consultants who similarly operated under FDA regulations and a company QMS.
Our CARS™ coaching is priced on a time and materials basis, and will vary depending on the dimensions and aspirations of the engagement. Please contact us to discuss your particular CARS™ coaching interests.