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Red Nucleus Training Institute

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Best Practices for CMO/CDMO Vendor Selection, Qualification, Contracting, & Oversight

Best Practices for CMO/CDMO Vendor Selection, Qualification, Contracting, & Oversight

Best Practices for CMO/CDMO Vendor Selection, Qualification, Contracting, & Oversight

~0.50 hrs | GMP - Manufacturing Controls

This module describes best practices for vendor selection, how to qualify selected vendors, and how quality agreements protect the interests of all parties by clearly defining CGMP-related roles and responsibilities for manufacturing products within a quality system.

Module Details

After completing this module, you will be able to:
• State the expectations of a product owner for qualifying and managing contract facilities
• Recall the content expectations for quality agreements between a product owner and a contract facility
• Recognize the expectations and legal responsibilities for each party as these relate to current good manufacturing practices (CGMP)

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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