Effective Complaint Handling, Medical Device Reporting and Recalls 2018 2026 2027 (37673)

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

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Effective Complaint Handling, Medical Device Reporting and Recalls 2018