Live webinar on The Fundamental Principles of Complaint Handling and Medical Device Reporting By Compliance2go October 31, 2012

Why should you attend :

The Food and Drug Administration’s (FDA) complaint handling requirements under the Quality System Regulation (QSR), 21 C.F.R. Part 820 and MDR reporting obligations under 21 C.F.R. Part 803 are usually some of the first items FDA will review when inspecting a firm’s facilities. The status of the inspected firm’s compliance with these requirements can directly influence the dynamics and outcome of the firm’s inspection in a positive or negative manner. This program is intended to provide firms with the understanding and insights they need to demonstrate compliance with these requirements and obligations.
Areas Covered in the Session:

Complaint handling requirements under 21 C.F.R. § 820.198.

MDR obligations under 21 C.F.R. part 803.

A review of the principles essential for compliance with FDA’s complaint handling and MDR requirements. This webinar will:
Demonstrate the importance of proper complaint handling processes in making accurate MDR reporting decisions.

Provide clarity on definitional and procedural issues, including “grey area” issues that can be unwittingly interpreted in a way contrary to how FDA would interpret these issues and a

Official Website: https://compliance2go.com/index.php?option=com_training&speakerkey=37&productKey=170