Combination Products – cGMP Requirements
FDA has issued a regulation on the current good manufacturing practice (cGMP) requirements applicable to combination products in an effort to improve the consistency of the regulatory requirements and implementation. This course discusses cGMP requirements and FDA rules that relate to combination products. Topics in this course include: Background, Final Rule, Compliance, The Office of Combination Products, 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.
Identify the four different types of combination products. Recognize the scope of the new regulation in 21 CFR Part 4, and each of the drug, device, and biological product rules. Identify the role of the Office of Combination Products (OCP). Recognize how post-marketing modifications are made and how to report post-marketing adverse events.