Red Nucleus Training Institute

Providing on-demand training solutions

Change Management

~0.50 hrs | GMP - Quality Systems

ICH Q10 describes change control as a “systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.” This module will present an interactive overview of what change control is, why it’s important, how it should be implemented, and measuring success.

Module Details

After completing this module, you will be able to:
• List the regulatory expectations for changes to validated processes
• Identify the areas to address and assess during the change process
• State the activities involved in the change implementation process
• Recognize areas where the change management process often has issues

Features

• Audio narration with on-demand full-text transcript
• Module-level interactive learning exercises and
self-check questions
• Fully cited and sourced from a blend of Red Nucleus
best practices and global health authority regulations
and guidance
• Updated annually
• SCORM compliant

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