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Investigational Device Accountability Webinar  

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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)

print this agenda print agenda for the Investigational Device Accountability Webinar training seminar

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