Complaint-Handling, MDR and Recall Management 2015

  • 19-20 Mar 2015
  • DoubleTree by Hilton Hotel San Diego Downtown, CA, United States

Description

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

The Complaint-Handling, MDR and Recall Management 2015 is intended for:

  • 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

Past Events

Important

Please, check "Complaint-Handling, MDR and Recall Management" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Customer Service, Management
Education: Training
Health & Medicine: Healthcare, Medical laboratories, Medical technology, Pharma

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