Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI`s 2017

Topics

• 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

Who should Attend

• 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