Unlock the Power of Agile in FDA-Regulated Environments!

Wednesday November 6, 2024 11:00 AM EST (16:00 UTC)

While FDA-regulated and QMS-governed organizations were slow to adopt Agile methods, many are now learning how to embrace Agile philosophies in the strict world of FDA regulations and quality management systems (QMS).

In this Scrum Pulse Webinar, Agile experts Jeff Lee and Kelly Weyrauch share lessons learned from real-world engagements in FDA-regulated environments. Discover how organizations, from startups to large enterprises, have successfully implemented Agile development frameworks while maintaining full compliance with FDA regulations and QMS.

What You’ll Learn:

• What the FDA Really Wants: Cut through the myths and confusion and gain a clear understanding of the FDA’s true expectations.
• Regulations, Guidance, and Standards—What’s the Difference?
  Uncover the distinctions between these critical aspects and how each impacts your Agile processes.
• Aligning FDA Requirements with Your Company’s Needs: The key takeaway of this session is understanding where FDA requirements end and where your company’s internal policies begin. Learn how to separate compliance essentials from unnecessary internal bureaucracy.

By the end of this webinar, you’ll walk away with a solid understanding of how to balance FDA compliance with the flexibility and speed of Agile, allowing your team to innovate while meeting regulatory expectations.