Biotechnology: An Overview of Compliance Considerations

This 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.

After this course learners will be able to recognize what a biotechnology-derived product is. identify why and how the food and drug administration (fda) regulates them. identify the key manufacturing process, as well as the challenges involved with working with these products. identify various controls for biotechnology-derived products.