Quality Regulations and Standards

Survey of Quality, Regulations, and Standards for Biotechnology

This Course-in-a-Box is about teaching quality and regulatory affairs. "Quality" products in this context means products that are suitable for their intended use and are free of defects and variability. Many vital biotechnology products have a medical or food application where a poor quality product can have serious adverse consequences. Therefore, in a biotechnology company, "quality" becomes complexly interwoven with regulatory affairs, that is, the means by which governments strive to protect consumers from defective products. Instruction in quality and regulatory affairs is essential in biotechnology curricula.

It can be challenging to develop a course in quality/regulatory affairs because this is a vast and complex field with many potential topics and pathways for instruction. This is also an area that can seem dry and uninteresting to beginning students. We therefore provide in this course not just one, but two example courses to show the decisions made by two instructors and the resources they use to teach.

In addition to the two example courses, we provide an outline that organizes the many topics included in this field.

Additionally, we provide a few more classroom and laboratory activities that are successfully used at Madison College when introducing concepts relating to quality/regulatory affairs.

Your contributions are also welcome. If you would like to contribute a teaching resource to this course, contact Lisa Seidman, [email protected].

What is in this collection of resources?

*Course-in-a-Box access:  To view additional materials, log in to your Bio-Link account.  If you are a biotech faculty member at a college or high school, join Bio-Link to get an account.  Note - it may take a few days to verify your faculty position and set up the account.