Certificate in Regulatory Affairs for Biotechnology

Overview

Bringing an approved biotechnology product to market requires innovation and discovery as well as the ability to successfully adhere to the guidelines, regulations and laws mandated by the Food and Drug Administration (FDA).

This four-course program, led by Dr. Antonio Moreira, provides participants with in-depth exposure to key areas associated with bringing a biotechnology product to market under FDA approval.

Courses are delivered at the UMBC campus and are videocast realtime to Frederick Community College in Frederick, MD. Remote students can view previously recorded lectures online.

A Non-Credit Certificate in Regulatory Affairs for Biotechnology will be awarded upon completeion of all four courses.

Courses

• Regulatory Issues in Biotechnology (Fall 2011)
• Good Manufacturing Practices for Bioprocesses (Spring 2010)
• Quality Control and Quality Assurance for Biotechnology Products (Fall 2010)
• Design, Construction, and Validation of GMP Biotechnology Facilities (Spring 2011)

Links

• FDA Website
• Other Biotech programs at UMBC