Effective Complaint Handling, Medical Device Reporting and Recalls 2015 2026 2027 (49996)

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

Effective Complaint Handling, Medical Device Reporting and Recalls 2015