Medical Device Recalls: How to Properly, Compliantly, and Promptly Deal with a Recall

11:00 AM ET | 8:00 AM PT | 10:00 AM CT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

"Listen from Kelly Thomas she has 20 years’ experience in leading facility start-ups, PAI and Routine cGMP Surveillance inspections."

Protects your firm from more severe action by the FDA

Description

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 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

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?

Who will Benefit

•         Clinical Trial Physician / Doctor
•         Manager to Senior Director of
•         Regulatory Affairs
•         Quality Assurance
•         Clinical Research
•         Data Management
•         Data Monitoring

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.  Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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