The Mindset of an FDA Employee

Why Should You Attend:

Productive interactions with FDA personnel are key to a successful company. By unstinting the mindset of FDA employees, you greatly increase the likelihood of productive interactions that will aid you company in the key area of FDA regulation.

For most firms the most common interaction with FDA this is dealing with an FDA Investigator during an FDA Inspection. But firms that get into trouble, it also means dealing with FDA Compliance Officers.

Also, for firms that develop or manufacture products requiring FDA approval, it means interacting with FDA Scientists, and Engineers.

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.

Areas Covered in the Webinar:

• 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.

Who Will Benefit:

CEO’s, COO’s, General Managers, Vice Presidents and Directors from key company functions of RA/QA and R&D Other Regulatory Professionals, Quality Assurance Professionals, and internal quality auditors. Industry consultants who work with FDA regulated firms.

Larry Stevens
RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert

J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also 18 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. Finally, a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. As a consultant he has presented over 20 webinars on FDA requirements.

Mr. Stevens has met numerous times with FDA as a member of industry, and with industry numerous times as an FDA Official. He is keenly aware of what pitfalls must be avoided, and what FDA expects from the firm with whom they are meeting. Now as a consultant, Mr. Stevens assists firms in meeting FDA requirements and conducting successful FDA meetings.

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