Understanding the Mindset of an FDA Employee
Tuesday, November 28, 2023
10:00 AM PST | 01:00 PM EST
Webinar ID: 501643
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Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
During this webinar we will provide information on the backgrounds of FDA employees, how FDA employees are trained, how they interact with the regulated industry.
We will also explore FDA managers and how they approach their job, which has a direct impact on how you try to resolve FDA problems.
If you assume the way an FDA employee's mind works, by using the model that you have seen in your private industry experience, you may find yourself very confused by actions and words of an FDA employee
Why should you Attend:
Any firm that develops and manufactures products regulated by FDA will need to deal with FDA employees.
FDA employees work in an environment that is completely different than the business world. Because of that they have different ways of dealing with encounters with outsiders.
This webinar will prepare you to understand how FDA employees act, and what to expect from you dealing with them
Areas Covered in the Session:
Who Will Benefit:
- Become familiar the types of jobs within FDA and the qualifications needed to serve
- Know what motivates an FDA employee • Know how FDA employees are trained
- Become familiar with the methods of dealing with FDA personnel to achieve a desired outcome
- Know how to meet with FDA and what to not say or do
- Know how to negotiate with an FDA manager to resolve issues
- Know how to train your own employees in methods of dealing with FDA
- General Managers
- Senior Executives from key company functions
- Regulatory Professionals
- Quality Assurance Professionals
- And Internal Quality Auditors
- Industry Consultants who work with FDA regulated firms
- FDA employees who might want to learn how they are viewed from the industry perspective
Lawerence Stevenshas a unique background of FDA and Industry experience. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He currently serves as an expert witness for cases involving FDA regulation compliance for medical devices. He regularly performs webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, he is a seasoned educator/speaker with over 150 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.