Month

November 2019

Understanding the Four Levels of Initiative

Initiative is “the energy or aptitude displayed in an initiation of action, or an introductory step,” says Merriam-Webster. In short, you need it to act—to move forward. The Four Levels of Initiative As a leader, it’s important to understand the four levels of initiative that your team exhibits. Knowing where they fall now can help...
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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. Why Choose CARS™ Certification? Although Agile methods don’t conflict with FDA regulations, they do often...
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CARS™ Certification: What It Is & Why It Matters

Agile product development within FDA-regulated industries requires determination, industry knowledge and skill. Each step in the process must comply with FDA regulations as well as your own Quality Management System (QMS). To help you successfully employ Agile in this environment, we offer our Certified Agile Regulatory Specialist™ (CARS™) program.     What Is CARS™? Our...
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Scrum & Status Reporting: Attend the Sprint Review

“How do we report status?” “How do I get insight into the product?” These are frequent questions we receive from our clients as they move to an Agile method like Scrum. The short answer to both of these questions is: eliminate status reports and attend the Sprint Review. After all, as the aphorism states, “there’s...
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