Effective Complaint Handling, Medical Device Reporting and Recalls 2015 is a seminar that covers topics such as:
- Complaint evaluation and investigation
- How Does the FDA Use Medical Device Reports?
- Understand the History of MDR Regulation
- Improve communication and teamwork on complaints across departments and functional areas
- Recall Responsibilities & Requirements
- Monitoring and Auditing Recall Effectiveness
- Reporting complaints
- Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
- Recall Termination
- Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
- Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
- Medical Device Recall Reporting
- Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
- FDA`s Role
- Recall Communication and Strategy
- Data collection and trending
- Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
- 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?
- Who can submit Voluntary Reports to the FDA?
- Basics of a Recall: Initiation, Classification and Public Warning
- Managers
- Introduction to Medical Device Recalls: Industry Responsibilities
- CAPA process for investigating complaints
Effective Complaint Handling, Medical Device Reporting and Recalls 2015 brings together:
- Operations/Manufacturing
- Quality Assurance Management
- Regulatory Affairs Management
- Compliance Specialist
- Engineering/Technical Services
- Regulatory Affairs Specialist
- Distributors/Authorized Representatives
- Auditors
- Legal Counsel
- Marketing & Sales
- Clinical Affairs
- Compliance Officer
- Consultants