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.

Topic Background:

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

Areas Covered

--  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
--  Biostatisticians
--  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

Speaker Profile

Larry Spears

As an independent consultant and President of L.Spears Consulting LLC, Larry provides a wide range of regulatory and compliance consulting services to the Life Sciences industry with particular focus on medical device and pharmaceutical post-market activities including regulatory gap audits and FDA Mock inspections, remediation to FDA 483s, Warning Letters and enforcement actions. He also continues to provide consulting services through various contractors including Certified Compliance Solutions, San Diego, CA. Previously served as a Director in Deloitte & Touche LLP's Health Sciences practice providing his FDA insights to assist clients in developing quality and risk strategies in areas such as regulatory governance, contract manufacturing, and validation prior to joining Certified Compliance Solutions, Inc as a Principal Consultant.

Has over 30 years experience with the Food and Drug Administration (FDA) as an investigator,
compliance officer, compliance manager and director. 

Gained considerable experience in inspection outcome management, regulatory case management, and recall evaluation/classification during his over 20 years at FDA's Center for Devices and Radiological Health

Has extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy 

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