Effective Complaint Handling, Medical Device Reporting and Recalls 2018

Topics

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

Who should Attend

Attendees from:

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