Red Nucleus Training Institute

Providing on-demand training solutions

Annual Product Reviews & Regulatory Submission Updates

~0.50 hrs | GMP - Quality Systems

Every year pharmaceutical manufacturers must conduct an annual product review (APR). This module defines what should be included in an APR and the different types of regulatory change submission updates required by the FDA.

Module Details

After completing this module, you will be able to:
• State the expectations for annual product reviews
• List the items to include in annual product reviews and recall why these items are important
• Identify the types of regulatory submission updates and recognize when each is used

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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