Effective Complaint Handling, Medical Device Reporting and Recalls - Avoiding Costly Errors: 2015

Key Topics

• Firms MDR reporting and FDA`s handling of reports
• How to comply with complicated Compliant Handling, MDR and Recall requirements
• Minimizing 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
• Creation and maintenance of effective procedures for handling complaints, reportable events and recalls
• Walk-through of case examples

Who should Attend

Attendees from medical device industry involved in recalls, product complaints and medical device reporting, including QA/QC, Regulatory Affairs, Regulatory Professional, Project Managers, Complaint Handling Teams, Risk Managers and CAPA Teams.