Effective Complaint Handling, Medical Device Reporting and Recalls 2015

Topics

• Complaint evaluation and investigation
• How Does the FDA Use Medical Device Reports?
• Understand the History of MDR Regulation
• Improve communication and teamwork on complaints across departments and functional areas
• Recall Responsibilities & Requirements
• Monitoring and Auditing Recall Effectiveness
• Reporting complaints
• Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
• Recall Termination
• Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
• Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
• Medical Device Recall Reporting
• Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
• FDA`s Role
• Recall Communication and Strategy
• Data collection and trending
• Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
• What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
• What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
• Who can submit Voluntary Reports to the FDA?
• Basics of a Recall: Initiation, Classification and Public Warning
• Managers
• Introduction to Medical Device Recalls: Industry Responsibilities
• CAPA process for investigating complaints

Who should Attend

• Operations/Manufacturing
• Quality Assurance Management
• Regulatory Affairs Management
• Compliance Specialist
• Engineering/Technical Services
• Regulatory Affairs Specialist
• Distributors/Authorized Representatives
• Auditors
• Legal Counsel
• Marketing & Sales
• Clinical Affairs
• Compliance Officer
• Consultants