Quality Regulations and Standards

Survey of Quality, Regulations, and Standards for Biotechnology

What is this “course”?

This Course-in-a-Box, CB, 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 CB 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 Area Technical 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 CB, contact Lisa Seidman, Lseidman@madisoncollege.edu.

What is in this collection of resources?

• Example On-Line Quality Course 1 (This is an entire course contributed by Austin Community College)
• Example Quality Training Course 2 (This is an entire training course contributed by Salt Lake Community College)
• Outline (The outline summarizes and organizes quality/regulatory affairs topics as they are presented in various courses, books, and quality literature.)
• Additional Instructional Resources (A small number of additional classroom and laboratory activities to supplement the example courses from Austin and Salt Lake.)
• Quality Courses and Programs (This links to quality courses and programs associated with Bio-Link programs.)
• Careers in Quality Control (Bio-Link Career Site)