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"The Rock", Alcatraz Island & National Park

Complaints, MDRs and Recalls for Devices

• Date: Monday, October 24, 2011
• 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 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. Last year, device companies had more Class 1 (most severe) recalls in history. 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. Outlines of MDR, Recall procedures will be provided along with related form templates. This course will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in complaint handling, medical device reporting (MDR), and correction & removal processes, including recalls. Rita Hoffman, previously the Recall Branch Chief for CDRH , will be one of our instructors as well as Jim Kozick, previous Director of Domestic Investigations, FDA Los Angeles District Office .

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 requires during an Inspection.

Benefits of Attending:

• Understand how to comply with complicated Compliant Handling, MDR and Recall 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
• C. Understanding Complaint Systems
• D. FDA Expectations: Complaint System Inspections
• E. Medical Device Reporting (MDR)
• F. Medical Device Reporting: FDA & Industry Perspectives
• G. Workshop: Complaints vs. MDRs...is it or isn't it reportable?!
• H. Corrective & Preventive Action System (CAPA)
• I. FDA's Medical Device Recall Process
• J. How Industry Should Handle Recalls
• K. Review & Summary
• L. Seminar Evaluation & Test
• M. Question & Answers- Panel

Speaker: Jim Kozick, Rita Hoffman, 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!