Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits 2017 covers topics such as:
- Firms MDR reporting and FDA`s of reports
- How to comply with complicated Compliant Handling , MDR and Recall requirements
- Minimize risk of regulatory enforcement actions
- Company preparation in the event of a Recall, 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
- Designing Standard Operating Systems for communicating process for firms success
- Walk-through of case examples
- FDAs New Guidances on and how it interacts with Recalls
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits 2017 brings together attendees with responsibilities in:
- QA/QC
- Regulatory Affairs
- Regulatory Professional
- Project Managers
- Complaint Handling Teams
- Risk Managers
- CAPA Teams
