Regulatory Compliance for Drugs & Biologics

Regulatory Compliance is that level of activity which provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act. In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for manufacturing, testing and control of clinical supplies and commercial products.

Course Number: BIOL-40101   Credit: 2 units

This course is part of the following Certificate Program(s):

• Biotechnology Manufacturing

• Clinical Trials Design and Management

• Quality Assurance and Control

• Regulatory Affairs Essentials

• Regulatory Affairs for the Biomedical Industry