As your students leave you and your program and find employment in the biotechnology industry, they will suddenly find themselves in a tightly regulated environment. The nature of biotech products requires this regulation by the FDA. Unless one is familiar with this environment, it can be challenging adapt and thrive in it as a worker and an contributor to the company's success. Thus, preparation for this regulated environment is important to student success in the transition from education to the workplace.
I put together the following presentation for a Bio-Link SFF 2013 workshop to show what are key considerations when working in a regulated environment and to provide you with suggestions on what you can do to help your students prepare for it.
Workshop details are below. Hope you see you there!
The biotechnology industry is heavily regulated by the Food and Drug Administration (FDA). While the FDA regulations have been in place for decades, companies still struggle with compliance. This workshop will provide an overview of the regulated environment: basics of FDA regulations, the mechanisms in place within companies to achieve compliance, and some of the common observations FDA inspections have revealed. This framework, along with suggested topics and activities from the presenter, will allow attendees to better prepare their students for working in a regulated environment and making positive contributions toward compliance.
For additional instructional materials on FDA regulations and quality systems prepared by the presenter, check out the Quality Training Course 2 in the Survey of Quality, Regulations, and Standards section of Bio-Link’s Courses in a Box resource.