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Medical Devices

Biotechnology: An Overview of Compliance Considerations

About the Course

This eLearning course provides an overview of the fundamental compliance issues impacting the biotechnology industry. Topics in this course include: Biotechnology-Derived Products (BDPs), Cell Culture, Antibody Production, Manufacturing Controls, Processing and Filling, BDP Controls, and Testing. After completing this course, learners should recognize what a biotechnology-derived product is, identify how FDA regulates them, and identify various controls for biotechnology-derived products.