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

01:00 PM ET | 10:00 AM PT | 12:00 AM CT Duration 180 Minutes

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

"Hear From Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries."

PR issues for your firm

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? 
•           Recall Termination

Who will Benefit

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

Industries who can attend

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


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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