Overview:
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.
Why should you Attend: Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly van lead to seizure multiple seizure, or other court action by the Food and Drug Administration. Effective Recalls, will minimize both the financial and PR issues for your firm, and will enable your firm to swiftly move to the phase of starting to re-build after an issue.
Areas Covered in the Session:
Session I- Determining and Initiating the need for a Recall
What is a Recall
Who can initiate a Medical Device Recall?
How to determine if you have a Medical Device Recall
Where and What Should Be Reported
Reports of Correction and Removal
Session II- Firm's Responsibilities and action points
Firm's Responsibilities for a Recall
Adverse Consequences or Risk to Health
Safety Alerts
A Firm's Recall Communication
A Firm's Recall Strategy
Firm's Follow-up Responsibilities
Quality System Requirements
Things to Consider When Recalling Your Medical Device
Recall Status Reports
Session III- FDA's expectations and Enforcement Policy
FDA's Enforcement Policy
FDA Expectations
FDA's Role
Recall Classification
What can FDA do when a firm is reluctant to conduct a recall?
Recall Termination
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.
Why should you Attend: Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly van lead to seizure multiple seizure, or other court action by the Food and Drug Administration. Effective Recalls, will minimize both the financial and PR issues for your firm, and will enable your firm to swiftly move to the phase of starting to re-build after an issue.
Areas Covered in the Session:
Session I- Determining and Initiating the need for a Recall
What is a Recall
Who can initiate a Medical Device Recall?
How to determine if you have a Medical Device Recall
Where and What Should Be Reported
Reports of Correction and Removal
Session II- Firm's Responsibilities and action points
Firm's Responsibilities for a Recall
Adverse Consequences or Risk to Health
Safety Alerts
A Firm's Recall Communication
A Firm's Recall Strategy
Firm's Follow-up Responsibilities
Quality System Requirements
Things to Consider When Recalling Your Medical Device
Recall Status Reports
Session III- FDA's expectations and Enforcement Policy
FDA's Enforcement Policy
FDA Expectations
FDA's Role
Recall Classification
What can FDA do when a firm is reluctant to conduct a recall?
Recall Termination
Who Should Attend
- Clinical Trial Physician / Doctor
- Manager to Senior Director of
o Regulatory Affairs
o Quality Assurance
o Clinical Research
o Data Management
o Data Monitoring
o Institutional Review Board
