Establishing a Medical Device Complaint Handling System integrated with a UDI System

DESCRIPTION
This webinar is intended to help you get familiar with how to implement a medical device complaint handling system integrated with a unique device identification (UDI) system.

This webinar is further intended to provide actionable information and guidance on how to meet the regulatory requirements for handling any complaints concerning all medical device types including in vitro diagnostic medical devices.
FDA regulations require all medical device manufacturers, user facilities, and importers to establish and maintain complaint handling procedures.
Understanding the relevant and applicable requirements, in particular, new requirements recently implemented, can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of time and efforts in business while ensuring the safety and effectiveness of the medical device products and customer satisfaction.

This webinar will discuss how to implement medical device complaint handling procedures/requirements. The speaker will also discuss how to achieve compliance, and to remain compliant with an adequate integration of the UDI system.

At the end of this webinar, you will have an opportunity to bring great values to your organization in a way to adequately implement your complaint handling system and save your significant amount of various resources.

Why should you attend :

According to FDA regulations, all medical device manufacturers, user facilities, and importers are subject to compliance with the complaint handling requirements. This webinar is intended to help you implement a medical device complaint handling system integrated with a UDI system.

Areas Covered in the Session:

Statutes and regulations
Definitions
What to do when complaints are received?
How to process complaints.
What processes need to be in place?
When to investigate complaints.
When to open a CAPA(s).
Contents of records of investigation.
Unique device identification/identifier (UDI) integration
Good practices: suggestions and recommendations
Lessons learned

Who will benefit:

CEOs
VPs
Compliance officers
Attorneys
Complaint handling personnel
Clinical affairs (associates, specialists, managers, directors or VPs)
Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality assurance (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
CROs
Consultants
Contractors/subcontractors
Anyone involved in the clinical trials or studies

Webinar Includes:

Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance