The FDA continues to focus on post-market surveillance, and one of the leading causes of Warning Letters is failure to implement an effective system to manage complaints. In addition, complaints can lead to MDRs, corrections, and removals. Warning Letters often cite implementation failures, or even no implementation, of these other systems. One reason that firms do a poor job is that these essential systems are not in Part 820, the Quality System Regulation, and are often misunderstood or ignored.

This presentation provides practical advice on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. We explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. For Servicing, our speaker explains the requirements to analyze service reports, shows how service reports can trigger MDRs, and automatically become complaints. The presentation reduces the regulatory language to simple English and explains how you can implement an effective and unified system.

The FDA regulations require three sets of documents: written procedures, records of activities, and reports to the FDA. This presentation explains the requirements in the multiple systems (complaint management, corrective actions, service management, risk management, and field upgrades) the manufacturer must implement.

This audio conference covers:

• The FDA requirements for complaint management
• The FDA requirements for service management
• The relationship between service and complaints and how they could lead to Medical Device Reports
• Establishing a unified system for complaints, corrective action, record keeping, and reporting
• The time requirements for reporting events to the FDA

About the speaker:

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who should attend?

• Quality Managers
• Quality Engineers
• Reliability Engineers
• Service Managers
• Manufacturing Engineers
• Service Engineers
• CAPA Specialists