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.  

How You Will Benefit:
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: There are no prerequisites.

Cost:
Half-day class
Cost: $125 (includes class, all class materials, and snacks)

Instructor Bio:  Linda J. Bovard, RAC
Linda J. Bovard is President of Bovard Consulting LLC. She provides regulatory consulting services to FDA-regulated companies, primarily in the medical device arena. Her services include strategic planning, pre-market submissions, labeling, training, and development, improvement, and auditing of Quality Systems. She has provided services to medical device companies for over 25 years, more than 15 years as a consultant. She has worked with entrepreneurs, virtual companies, start-ups, established small companies, and large conglomerates. Products range from sophisticated electronic devices with software to IVDs to personal use devices. Linda has a BA in Biology from Swarthmore College. She is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society and is a Certified Hazardous Materials Manager (CHMM) from the Institute of Hazardous Materials Management. She is committed to continuing education to keep up-to-date in this constantly changing field. She also passionately believes that understanding FDA is crucial for the success of regulated companies.