Overview of FDA Requirements for Regulated Industries – Online

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Name: Overview of FDA Requirements for Regulated Industries – Online
Date: July 21, 2020
Time: 1:00 PM - 5:00 PM PDT
Event Description:
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. Cost: Half-day class
Oregon Bio Virtual Classroom
Date/Time Information:
July 21 from 1:00-5:00
Contact Information:
Julie Black Director of Member Services Oregon Bioscience Association 503-953-3145
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