Effective Strategy for Medical Device Recalls 2015

Topics

• Things to Consider When Recalling Your Medical Device
• What is a Recall and how to determine if you have one?
• Who can initiate a Medical Device Recall?
• Adverse Consequences or Risk to Health
• Reports of Corrections and Removals
• Where and What Should Be Reported?
• Company’s Recall Communications, Strategy and follow-up responsibilities
• Company’s Responsibilities for a Recall
• Recall List
• Quality Control Program
• Recall Termination
• Recall Status Reports
• FDA’s Role and Expectations
• FDA Compliance policy guide’s
• Safety Risk Management
• What can FDA do when a firm is reluctant to conduct a recall?

Who should Attend

• Quality Assurance Managers
• Regulatory Affairs Managers
• Data Management Personnel
• Clinical Research Managers
• Clinical Trial Physicians
• Data Monitoring Personnel
• Institutional Review Boards