Understanding and Implementing the EU Vigilance System 2016 is a webinar that covers topics such as:
- The role of MEDDEV documents in the EU system
- An overview of the EU Vigilance System
- The timing of adverse event reports, including their classification
- The conditions that require an EU adverse event report
- Trending of complaints and required reporting after recognizing a "signal"
- Developing Periodic Summary Reports to help reduce the quantity of reports
- The two elements of recalls - the Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
Understanding and Implementing the EU Vigilance System 2016 is intended for attendees from:
- Management Representatives
- Regulatory Managers
- Compliance Managers
- Quality Managers
- Audit Managers
- Notified Body Liaison
- Complaint and Incident Specialists
