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Red Nucleus Training Institute

Providing on-demand training solutions

Sterile Manufacturing & Key Challenges

Sterile Manufacturing & Key Challenges

Sterile Manufacturing & Key Challenges

~0.50 hrs | GMP - Manufacturing Controls

Many of the therapeutic products life sciences companies bring to market require sterility. This is especially true of complex biologics, injectables, and implantable medical devices. This module provides an overview of the requirements for facilities, management, and personnel.

Module Details

After completing this module, you will be able to:
• State what sterile manufacturing is and why it’s important
• List the elements that make up successful sterile manufacturing operations
• Identify the key requirements for successful sterile processing facilities and operations
• State personnel expectations to ensure an effective sterile production operation


• 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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