Complaint Handling & Medical Device Reporting (MDR) 2016 is a webinar that covers topics such as:
- Definitions
- Applicable Laws and Regulations
- Requirements for Medical Device Reporting
- Requirements for Complaint Handling
- Key Elements in the Procedures: Complaint Handling and MDR
- Applicable Processes and Procedures
- What/How/When to Investigate a Complaint
- What to Do When a Complaint Is Received
- Medical Device Reporting
- Complaints Investigation and Documentation
- Establishing Reportability Criteria
- How to Determine Reportable Events
- Mistakes and How to Avoid Mistakes and 483s
- Additional Documentation Requirements for MDR
- Enforcement Case Studies
- Relationships between Complaint Handling, MDR, and CAPA
- Speaker’s PASS-IT suggestions and recommendations
- Improving Our Awareness and Continuous Improvement
Complaint Handling & Medical Device Reporting (MDR) 2016 is intended for:
- Regulatory Affairs
- Complaint Managers
- Clinical Affairs
- Quality
- Compliance and Legal Affairs
- R&D engineers and scientists, managers, directors, VPs
- Auditors and Consultants
- CRO
- Anyone Interested in Medical Device Complaint Handling Systems
- Senior Management
