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Quality Assurance and Control

Regulatory Compliance for Drugs & Biologics

Regulatory Compliance is the level of activity that 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):

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Upcoming Sections

Section ID Fee Status
03/31/14 - 06/02/14   (Click to show details) Online 101047 $525.00 Closed
07/07/14 - 09/08/14   (Click to show details) Online 102885 $525.00 Add to Cart