A Kaplan EduNeering course

This course provides an overview of the fundamental compliance issues impacting the biotechnology industry.  It examines compliance requirements specific to the biotechnology processes such as: cell culture and fermentation; culture media and growth; antibody production; extraction, isolation, and purification; cleaning procedures; and laboratory controls and testing.  After completing this course, you will recognize what a biotechnology-derived product is.  You will also be able to identify why and how FDA regulates them.   You will also be able to identify the key manufacturing process for these products, as well as recognize the challenges involved with working with these products.  Finally, you will be able to identify various controls for biotechnology-derived products.

Topics include:
      ·          BDPs
      ·          Cell culture
      ·          Antibody production
      ·          E-I-P
      ·          Processing and packaging
      ·          Controls
      ·          Testing