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Seminar Summary:

Learn what is an Investigator responsibility, applicable regulations and guidance, definition of accountability, investigational device ordering and receipt, more. (see full course description)

 
 
 

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Training Course Syllabus:


Investigational Device Accountability Webinar

Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Sarah Fowler Dixon


Description:

Investigational device accountability ensures that the investigational (non-FDA approved) devices are used only as described in IRB approved protocols under the direction and management of appropriately qualified research team members.

Why Should you Attend:

Investigational device accountability is outlined in the FDA´s regulations. This webinar includes: Receipt, storage, distribution, reconciliation, return and authorized destruction of investigational devices. Many industry sponsors already have standard operating procedures outlining these policies, but, there are instances when a standard operating procedure or guideline does not exist, and those working with these devices need to know their responsibilities.

Objectives of the Presentation:


  • Define investigational devices

  • Review the regulations and guidance

  • Discuss device accountability requirements

  • Examine sample materials


Seminar Summary:

Learn what is an Investigator responsibility, applicable regulations and guidance, definition of accountability, investigational device ordering and receipt, more. (see full course description)

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