Red Nucleus Training Institute
Providing on-demand training solutions
Annual Product Reviews & Regulatory Submission Updates
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.
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
• 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
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