FDA Guidance: Medical Device Recalls By Ex FDA investigator
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Join This course On, May 17th 2017 at 01:00 PM EST
This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.
Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the FDA. A 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.
A recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the FDA. A request by the FDA 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 FDA. 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.
This webinar will discuss FDA guidance on medical device recalls
-- 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
-- Firm’s Responsibilities for a Recall
-- FDA’s Enforcement Policy
-- Adverse Consequences or Risk to Health
-- Safety Alerts
-- Firm’s Recall Communication
-- Firm’s Recall Strategy
-- Firm’s Follow-up Responsibilities
-- Quality System Requirements
-- Things to Consider When Recalling Your Medical Device
-- Recall Status Reports
-- 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
-- Regulatory Affairs Personnel
-- Quality Assurance Managers
-- Clinical Investigators
-- Institutional Review Boards
-- Data Monitors
-- Clinical Trial Physician / Doctor
-- Data Management Professionals
-- Data Monitoring Committees
Industries who can attend
This 90-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