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
Past Events
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits 2017 - 19-20 Oct 2017, Minneapolis, Minnesota, United States (67235)
Important
Please, check "Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits" official website for possible changes, before making any traveling arrangements
