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Recorded Webinar
Understanding the Mindset of an FDA Employee
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. For most firms this means 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.
Your instructor has been both an FDA employee and an employee in private industry. In addition he has been a high level FDA manager, and a senior executive in private industry, thus he has truly lived in two different worlds, and can speak from personal experience.
Key goals of the Webinar will include:
Who should attend
This topic applies to personnel / companies conducting FDA Regulations & FDA Meetings: The employees who will benefit most include:
However, if you are already familiar with the Sponsor-Investigator process in clinical trials, you may recommend this webinar to anyone in your company or research facility that might benefit from this course.
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