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Red Nucleus Training Institute

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ICH Q8/Q9/Q10 Deep Dive

ICH Q8/Q9/Q10 Deep Dive

ICH Q8/Q9/Q10 Deep Dive

~0.50 hrs | GMP - Quality Management

This module will provide details about the ICH guidance documents that have been adopted to define a pharmaceutical quality system (PQS). These documents encompass a modernized approach to product development, address expectations for a quality risk management process, and define a quality system framework for overseeing risk management performance.

Module Details

After completing this module, you will be able to:
• List ICH Q8/Q9/Q10’s intended benefits for both the manufacturing industry and regulatory agencies
• State the purpose and scope of each guidance and how each is applied in industry practice
• Identify the elements of an ICH Q10 pharmaceutical quality system


• 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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