Conference Description:

An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided.

Objectives of the Presentation:

>. Understand the basics of an FDA Inspection
>. Creating an inspection preparedness plan
>. Preparing your team and SMEs
>. Checklists for preparedness
>. How to manage an inspection at your facility


Areas Covered in the Session:

>. General Information about Inspections
>. Common mistakes
>. Planning for an inspection
>. Pre-inspection activities
>. When the inspection is announced
>. Checklists by area
>. During the inspection
>. After the inspection
>. Guidance for a 483 response


Who Should Attend:

>. Individuals new to Medical Device companies
>. Managers in functions outside of Quality wanting to prepare their organizations for an FDA inspection
>. Individuals that may be called in as subject matter experts during inspections
>. Compliance Personnel who will be the key contact during an FDA Inspection