Dealing Medical Device Recalls in 2019

LIVE  Feb 08, 2019 1:00PM EST

Duration : 60 min

23 days ago

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The webinar by Kelly Thomas will help you how to properly, compliantly and promptly Deal with a Recall.


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.

Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. A request by the Food and Drug Administration that a firm recall a device is reserved for urgent situations and is to be directed to the firm that has primary responsibility for the manufacture and marketing of the device that is to be recalled.


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 can lead to seizure multiple seizures,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.


Session Highlights:


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


· QualitySystem Requirements


· Things to Consider When Recalling Your Medical Device


· Recall Status Reports


Session III – FDA’s expectations and Enforcement Policy 2019


· FDA’s Enforcement Policy


· FDA Expectations


· FDA’s Role


· Recall Classification


. What can FDA do when a firm is reluctant to conduct a recall?




Who will benefit:


.  Quality Assurance Professionals

.  Regulatory Affairs Professionals

.  Professionals from the Pharmaceuticals, Biotech, Medical Device

.  Anyone involved with FDA

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