Overview:
The FDA has more power to affect regulated companies than almost any other organization, yet many people don’t understand it. Many others ignore it as much as possible. But the FDA affects the job of every person in a medical device or drug company. This course is designed to provide participants with insight into what the regulations are, why they are there, where they fit together, when they apply, and how to interpret them. We will not just discuss Quality Systems and Good Manufacturing Practices, but also submissions, registration, clinical trials, recalls, and adverse event reporting. Each participant will develop a better understanding of the environment in which their company exists and how they can help their company thrive.

By the end of the course, participants will have gained:

Familiarity with FDA concepts and organization
An understanding of how their jobs are impacted by FDA regulation and how they can lessen the regulatory burden on their company
Awareness of the most important regulations
Ways to think about regulation constructively and creatively
Information resources for further knowledge acquisition
Course Outline:

FDA Organization and philosophy
Overview of the types of regulations
Medical device regulation throughout the product lifecycle
Drug regulation throughout the product lifecycle
How to approach regulations
Navigation of the FDA website

Who Should Attend:
Anyone working in a medical device or drug company! Specifically, managers, supervisors, and personnel in manufacturing, engineering, quality assurance, or related disciplines.

Prerequisites:
No prerequisites.