Conference on Investigational Device Accountability

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

Learning objectives:

• Define investigational devices
• Review the regulations and guidance
• Discuss device accountability requirements
• Examine sample materials

Why should you attend: 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. 

Areas Covered in the Session:

• Investigator Responsibility
• Applicable regulations and guidance
• Definition of Accountability
• Investigational device ordering and receipt
• Investigational device storage
• Investigational device requisition and use
• Investigational device disposition

Who Will Benefit:

• Investigators
• Researchers
• Research Staff
• Study Coordinators
• Auditors
• Research Administrators

Price : $139.00

Contact Info:

MentorHealth
Phone No: 1-800-385-1607
FaX: 302-288-6884
support@mentorhealth.com
Event Link:

http://www.mentorhealth.com/