Red Nucleus Training Institute
Providing on-demand training solutions
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.
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
• Fully cited and sourced from a blend of Red Nucleus
best practices and global health authority regulations
• Updated annually
• SCORM compliant
Interested in learning more about this course?