This presentation provides the framework to understand the most common MDR problems: procedures, reporting, and records. The regulation has a section for each area that states the requirements; the presentation explains them. In addition, the presentation covers the role that complaints play in managing the MDR process.
To help understand the requirements for procedures, the presentation uses the most commonly cited problems in Warning Letters. FDA often uses “stock” language to point out these deficiencies, so identifying these common problems can help make your procedures better able to pass an FDA Inspection.
Objectives of the Presentation
Why should you Attend
- Learn the required content of your MDR procedures
- Analyze the reporting criteria for an MDR
- Understand special cases, such as contract manufacturers
- Learn the timing for an initial MDR and any follow-up
- Review the required records for an eMDR submission
- Learn the impact of UDI on the MDR requirements
- Understand the linkage between complaints and MDRs
- Understand auditing as a preventive measure
Because MDR implementation is one of the most frequently cited areas in Warning Letters, the conclusion is that most companies don’t have a good understanding of the requirements. This presentation, with its analysis of Warning Letter citations, provides the information you need to ensure your implementation robust, and will pass Inspection.
Who will Benefit
People in the following roles can especially benefit from the knowledge in this presentation:
- Quality Managers
- Quality Engineers
- Quality Auditors
- Regulatory Managers
- MDR Handling Specialists
- Complaint Handling Specialists
- Risk Managers
- Data Analysts
Attendees receive a checklist based on the MDR regulation, Guidance Documents, Warning Letters, and QSIT to help ensure compliance.