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Pharmaceuticals, Medical Devices

Combination Products – cGMP Requirements

About the Course

The U.S. Food and Drug Administration (FDA) has issued a regulation on the current Good Manufacturing Practices (cGMP) requirements applicable to combination products in an effort to improve the consistency of the regulatory requirements and implementation. This online compliance training discusses cGMP requirements and FDA rules that relate to combination products. Topics in this eLearning course include: Background, Final Rule, Compliance, The Office of Combination Products (OCP), and Post-Approval Modifications. After completing this course, learners will be able to recognize the four different types of combination products and the scope of the regulation in 21 CFR Part 4. They will also be able to identify how to comply with each of the drug, device, and biological product provisions and handle post-marketing events.