Course Overview

Agile Methodology in System Validation

This training focuses on adapting computerized system validation in regulated environments using Agile principles, offering practical tools and insights for industry professionals.

Objectives

• Agile principles: Understand core Agile concepts and their use in system validation.
• Validation strategies: Learn adaptable techniques for Agile-driven validation.
• Compliant documentation: Create user stories, test cases, and compliant documentation within Agile, linking to CSA and GAMP 5.
• Risk assessment: Develop methods to assess and manage risks in Agile environments.
• Seamless integration: Integrate Agile practices smoothly into validation workflows.

Target Audience

Managers, production, lab, and QA staff in (bio)pharma, medical devices, healthcare, or food industries working with or transitioning to Agile methods.

Program

Day 1

13:00     Day 1

• Module A – Introduction and terms
• Module B – Scrum and SAFe
• Module C – When to use Agile
• Module D – User stories

Day 2

09:00 Day 2

• Module E – Planning and execution
• Module F – Verification
• Module G – Documentation Waterfall vs Agile
• Module H – Operation
• Module I – Continuous Improvement & regression testing automation

• Experience working in an Agile (Scrum) Team

Other Details