San Diego, Ca
San Diego, California

Course Description:
Medical Device Reporting (MDR) and recall compliance are critical to the reputation and survival of all device manufacturers. The FDA is serially issuing numerous FDA Warning Letters and serious enforcement actions, including criminal and civil penalties levied on companies that failed to properly report events and take proper corrective and removal action. This interactive one and half a day seminar will give the tools to minimize risk of regulatory enforcement actions, medical device complaint handling, how and when to file Medical Device Reports (MDR). This course will provide an understanding of MDR & Recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management Processes.
Learning Objectives:
Main objective of this course is to give an understanding on how to comply with complicated Compliant Handling, MDR and Recall requirements. It will provide training on the following topics:
• 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 the risk of regulatory enforcement actions.
• Product Retrieval Issues, Effectiveness Checks and Status Reports
• Evaluating Risk and Health Hazard Evaluation
• Developing effective Strategies and Communicating with FDA
• Termination of a Recall
Who will benefit:
The course will benefit to the following personnel in the medical device industry that handles functions involving product complaints, recalls, medical device reporting:
• Regulatory Affairs
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams

Official Website:

Added by complianceonlinecom on November 21, 2012