is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, June 8th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
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.
