Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits 2017

Topics

• 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

Who should Attend

Attendees with responsibilities in:

• QA/QC
• Regulatory Affairs
• Regulatory Professional
• Project Managers
• Complaint Handling Teams
• Risk Managers
• CAPA Teams