Agile validation in GxP

Agile Validation in GxP based on GAMP 5

Learn how to apply Agile methodologies in GxP-regulated environments while maintaining compliance with GAMP 5 guidelines. This course is designed for professionals who want to make software validation more efficient, flexible, and aligned with modern practices.

👉 Enroll now on Udemy and start implementing Agile Validation in your organization today.

What you will learn

• Fundamentals of Agile Validation in GxP-regulated environments.
• Mapping between traditional V-Model/GAMP 5 and Agile (Scrum) workflows.
• Creating User Stories, Definition of Ready & DoD (Definition of Done).
• Testing strategies in Agile Validation, continuous validation, sprint & product definitions.
• How to plan and perform validation reports and validation plans under Agile.
• Balancing documentation, traceability, and regulatory compliance with Agile efficiency.

Who should join

• QA and Compliance Professionals in GxP industries.
• Validation Specialists familiar with CSV transitioning to Agile.
• Developers, Scrum Masters, Agile Coaches, and Cross-functional Teams.
• Consultants or Auditors supporting GxP compliance.

Why take this course?

• Modern approach: Integrate Agile with regulatory requirements (GxP, GAMP 5).
• Efficiency & flexibility: Reduce waterfall overhead while maintaining compliance.
• Career advantage: Gain expertise in Agile Validation in regulated industries.

👉 Ready to transform your validation process? Click here to enroll today.