If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. Knowing what makes FDA employees the way they are, will help immensely in understanding how to deal with FDA.
Why Should You Attend:
Knowing the background and working conditions of FDA employees, you will better be prepared to deal with FDA. You will be able to assess the FDA person, and then use the information from this webinar, to improve your understanding of FDA, improve your communications with FDA and the overall FDA experience.
For most firms the most common GES dealing is with an FDA Investigator during an FDA Inspection. But firms that get into FDA trouble, it also means dealing with FDA Compliance Officers. In addition, 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:
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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.