The Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI`s 2017 is a course that covers topics such as:
- Firms eMDR/ MDR reporting and FDA`s of reports and UDI requirements for recalls
- How to comply with complicated Compliant Handling , MDR, eMDR and Recall requirements
- Minimize risk of regulatory enforcement actions
- Company preparation in the event of a , recall strategy, notification letter and communicating with the FDA
- The relationship and interaction with other quality system elements as they relate to complaints and reportable events
- Assist with the creation and maintenance of effective procedures for complaints, reportable events and recalls
- Navigating the maze of New Draft and Final FDAs Guidances with Post-compliance issues
The Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI`s 2017 brings together:
- Regulatory and Compliance professionals responsible for FDA interactions
- Quality Assurance and Quality Control personnel responsible complaint handling and recalls
- Risk Managers
- Project Managers responsible for maintenance of Complaint Handling, troubleshooting, and understanding QSR
- Complaint handling units
- CAPA Teams
- Compliance officers
- Auditors
- Regulatory/legislative affairs professionals
- Consultants/service providers
- Regulatory affairs reporting units
- IT department supporting complaint handling
