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

Future Events

Effective Complaint Handling, Medical Device Reporting and Recalls 2020

Important

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

Prices are for evaluation only.

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