Red Nucleus Training Institute

Providing on-demand training solutions

Global Regulatory & Compliance Overview

~0.50 hrs | GMP - Global Regulations & Compliance

This course will provide you with a detailed overview of the requirements for manufacturing and quality control as outlined by major global health authorities (HA). Content will also cover standards organizations, industry cooperatives, and global guidance. This module will also take you through key differences–and similarities–between specific requirements of each HA.

Module Details

At the completion of this module, you will be able to:
• List the major global regulatory agencies
• Identify the requirements manufacturers must meet for each of the major global markets
• Recognize some of the key differences between regulations in the US and EU
• State what mutual recognition agreements do for regulatory agencies and what it means for industry manufacturers

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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