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"The Rock", Alcatraz Island & National Park

Complaints, MDRs, Recalls & Vigilance for Devices

• Date: Wednesday, October 27, 2010
• Location: Embassy Suites on the Bay , Burlingame, California USA (near San Francisco International Airport (SFO))

Overview:
 
Complaint Handling, Medical Device Reporting (MDR), and recall compliance are critical to the survival of all medical device manufacturers. Numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties, have been levied on companies that failed to properly report events and take proper corrective and removal action when necessary. Besides regulatory compliance, the product liability and financial risks are staggering when companies fail to properly report and take action when required. Internationally, companies that fail to comply with Vigilance requirements risk losing their CE Mark and the ability to market their products in Europe. This course will provide attendees with an understanding of MDR, Recall, and Vigilance compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. Group Workshops and examples will be discussed to help clarify difficult questions and critical decision making that is needed during the process. In addition to the U.S. FDA requirements, Europe and Canada will be discussed. Outlines of MDR, Recall, and Vigilance procedures will be provided along with related form templates. This course will be beneficial to all medical device manufacturers and is recommended for any individuals or teams that are involved in complaint handling, medical device reporting (MDR), and corrective & removal processes, including recalls.

What you will learn:

• How to properly document product complaints.
  
• Understand the relationship of the CAPA and Risk Management processes as they relate to complaints, reportable events and recalls.
  
• How and when to file Medical Device Reports (MDR).
• How and when to appropriately conduct a correction and removal, including required recordkeeping.
• How to communicate with the appropriate regulatory agencies in the event of a recall.
• What to expect from FDA and other regulatory agencies in the event of a recall.
• Key factors in implementing and maintaining compliance with the regulations.
• What FDA and Notified Bodies require during an Inspection.

Benefits of Attending:

• Understand how to comply with complicated MDR, Recall and Vigilance requirements.
• Company preparation in the event of a Recall.
• 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.
• Learn from real life experiences of FDA and Industry Veterans.

Abbreviated Outline:

• A. Introduction
• B. Overview: Complaints, MDRs, Recalls & Vigilance
• C. Understanding Complaint Systems
• D. FDA Expectations: Complaint System Inspections
• E. Medical Device Reporting (MDR)
• F. Medical Device Reporting: FDA Perspective
• G. Workshop Complaints vs. MDRs
• H. Corrective & Preventive Action System (CAPA)
• I. CDRH's Medical Device Recall Process
• J. Recall Workshop
• K. Understanding Vigilance
• L. Review & Summary
• M. Seminar Evaluation & Test
• N. Question & Answers- Panel

Speaker: Jim Kozick, Rita Hoffman (Recall Branch Chief, U.S. FDA, CDRH), Christine Posin

Registration & Additional Information : Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.

On-line Registration Form Register on-line to reserve your seat now!