Understanding the Mindset of An FDA Employee

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.   

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.

Why Should You Attend

A negative interaction with FDA can cause major problems for your company.  i.e. long FDA 483, long delay in the review of regulatory submission, long inspections, etc.

Objectives of the Presentation 
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 your company in the key area of FDA regulation. 

 Areas Covered in the Session 

•  Become familiar with the types of jobs within the 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 the desired outcome
•  Know how to meet with the 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 the FDA.

Who Will Benefit 

•  Senior management
•  RA/QA professionals
•  R&D management
•  Regulatory consultants