Validation using Agile

Short description

Agile methodology is renowned for its adaptability; this training provides insights on how to tailor computerized system validation in regulated environments according to the Agile principles.

This programme provides insights and practical tools for professionals engaged in the validation of automated systems using Agile methodology. By participating in this course, you will improve your ability to navigate in the ever-changing landscape of automated system validation, aligning perfectly with industry standards.

Objectives

• Mastering agile principles: delve into the foundational principles of Agile, understanding its practical applications in the validation of computerized systems.
• Agile validation strategies: acquire effective strategies for seamlessly implementing Agile in the validation process, ensuring adaptability and responsiveness to evolving requirements.
• Improve your ability to create compliant documentation, user stories and test cases within the Agile framework, all in line with the highest regulatory standards, including the link to CSA and GAMP5 second edition.
• Agile risk assessment: develop advanced techniques for identifying, assessing, and mitigating risks associated with computerized system validation in Agile environments.
• Seamless integration of Agile into validation: strengthen your ability to interpret and integrate Agile methodology seamlessly into the computerized system validation process, ensuring a harmonious and efficient workflow.

Target group

Managers, production staff, laboratory staff and QA staff working at a (bio)pharmaceutical, medical device, healthcare or food company working in an Agile way or transitioning to an Agile way of working.