Effective Complaint Handling, Medical Device Reporting and Recalls 2018 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 2018 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