Overview: Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time. An integrated system addresses multiple elements: Designated individuals and their required skill setsProcedures to define the process and standardize workRecords to maintain and their prescribed contentReports to file with regulatory agencies and their timeframe The workshop covers all of these elements and includes checklists to help you integrate them into your QMS.To help clarify the issues, the workshop includes FDA Warning Letters. These Warning Letters illustrate problems that other companies have had so you can avoid them. The workshop also includes hands-on exercises for practical applications. Why should you attend? In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.