Conference Description:

Learning Objectives:
Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
Firms MDR reporting and FDA's handling of reports
Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
Minimize your risk of regulatory enforcement actions
Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
Walk-through of case examples
Step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success
Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls
Who Will Benefit:
This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

Regulatory Affairs
QA/QC
Project Managers
Regulatory Professional
Risk Managers
Complaint Handling Teams
CAPA Teams

Topic Background:
Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required.

This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.