Medical Device Complaint Handling, Event Reporting, and Recall Management Training
Regulatory investigations and third-party audits often begin by examining complaint data because its appropriate management is essential to an effective QMS. Given newly accelerated timelines for reporting events of harm or potential harm in the EU and other countries, as well as an increased focus by US FDA, efficient complaint identification, investigation, and decision making has never been more critical. During this training, participants develop skills to increase effectiveness and efficiency throughout the complaint-handling process and understand how their efforts contribute to regulatory compliance, product improvement, and customer satisfaction.