Effective Complaint Handling, Medical Device Reporting and Recalls


Effective Complaint Handling, Medical Device Reporting and Recalls is a seminar that covers topics such as:

  • 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

Effective Complaint Handling, Medical Device Reporting and Recalls brings together 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

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Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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