Complaint-Handling, MDR and Recall Management 2015 2026 2027 (50308)

The Complaint-Handling, MDR and Recall Management 2015 is dedicated to effective complaint handling.

The Complaint-Handling, MDR and Recall Management 2015 is a seminar that deals with

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

Complaint-Handling, MDR and Recall Management 2015