FDA Guidance: Medical Device Recalls 2014 is a webinar that covers topics such as:
- Who Can Initiate a Medical Device Recall?
- What Is a Recall
- Where and What Should Be Reported
- How to Determine If You Have A Medical Device Recall
- Firm’s Responsibilities for a Recall
- Reports of Correction and Removal
- Adverse Consequences or Risk to Health
- FDA’s Enforcement Policy
- Firm’s Recall Communication
- Safety Alerts
- Firm’s Follow-up Responsibilities
- Firm’s Recall Strategy
- Things to Consider When Recalling Your Medical Device
- Quality System Requirements
- FDA Expectations
- Recall Status Reports
- Recall Classification
- FDA’s Role
- Recall Termination
- What Can FDA Do When A Firm is Reluctant to Conduct A Recall?
FDA Guidance: Medical Device Recalls 2014 brings together:
- Quality Assurance Managers
- Regulatory Affairs Personnel
- Biostatisticians
- Clinical Investigators
- Data Monitors
- Institutional Review Boards
- Data Management Professionals
- Clinical Trial Physician / Doctor
- Data Monitoring Committees
