Course Details

Regulatory Compliance: Product Approval & Life Cycle Issues

In this course, students will be exposed to current Good Manufacturing Practices (cGMPs), which regulate the Biopharmaceutical Industry. Students will learn how companies interpret the regulations to comply with the spirit of the law as well as the legal implications they face when they don’t comply. This will be accomplished in a series of lectures that cover; - Biopharmaceutical product development and approval, i.e., how to get a drug commercially approved for sale, - Post-approval, modifications/improvements required to keep pace with changes in; regulations, market competition, needs of a diverse patient population, manufacturing costs, i.e. product lifecycle maintenance “LCM”, - What it means to operate in compliance with cGMPs and how FDA monitors and enforces cGMP regulations. What happens when companies fall into non-compliance and how non-compliance can escalate; i.e., form 483 observations, warning letters, consent decrees, etc., - A deep dive into understanding the breadth and depth of impact non-compliance both internal and external to the company. On completion of this course students should have: an appreciation for the regulatory landscape for life science product development, an appreciation of factors impacting a company’s ability to achieve and maintain compliance and the trade-offs that must be made, an understanding of how you, as a patient or caregiver, are impacted by pharmaceutical non-compliance, and how far reaching the impacts of non-compliance can be. As part of an intensive course project, that runs in parallel with lectures, students will evaluate business trade-offs and the impact of each to maintain compliance while ensuring sustainable drug supply to meet demand. At the end of the course students will present their deep dive assessment of real life, current warning letter situations affecting local biopharmaceutical companies. Prerequisites: Regulatory Strategy & Communication

Catalog Number: REGLAW 980-0


Course History

Spring 2018
Title: Regulatory Compliance: Product Approval & Life Cycle Issues
Faculty: Ayd, Sharon W
Section: 1     Credits: 1.5
Capacity: 24     Actual: 12