Effective Strategy for Medical Device Recalls. - By Compliance Global Inc. - PowerPoint PPT Presentation
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Effective Strategy for Medical Device Recalls. - By Compliance Global Inc.
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FDA 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 (FDA). 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. – PowerPoint PPT presentation
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Title: Effective Strategy for Medical Device Recalls. - By Compliance Global Inc.
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Toll Free 1-844-746-4244 support_at_complianceglob
al.us
Compliance Global Upcoming Webinar
- .
.
Effective Strategy for Medical Device Recalls.
Speaker Larry Spears Tuesday , August 18th
0100 PM EST
Compliance Global Inc 2015
www.ComplianceGlobal
.us
2
Upcoming Webinar of Larry Spears
Effective Strategy for Medical Device
Recalls. Tuesday , August 18th 0100 PM
EST Overview FDA 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
(FDA). 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. Recalls may be
undertaken voluntarily and at any time by
manufacturers and distributors, at the request of
the FDA or by a mandatory recall order from FDA.
Recall requests and orders by the FDA are
reserved for urgent situations and are to be
directed to the firm that has primary
responsibility for the manufacture and marketing
of the device that is to be recalled.
Compliance Global Inc 2015
www.ComplianceGlobal.us
3
Upcoming Webinar
of Larry Spears Effective Strategy for Medical
Device Recalls. Tuesday , August 18th 0100 PM
EST Why Should You Attend Recalling medical
devices that present a hazard to consumers
supports public health safety and protects
companies from more severe action by the FDA (or
other regulatory agencies). Not performing a
recall correctly can lead to seizure actions by
the FDA or other court actions. Effective Recalls
will minimize both the financial and public
relations issues for your company and will enable
you to move beyond the effects of a recall much
more quickly.
Compliance Global Inc 2015
www.ComplianceGlobal.us
4
Upcoming Webinar of Larry Spears
Effective Strategy for Medical Device
Recalls. Tuesday , August 18th 0100 PM
EST Areas Covered in the webinar What is a
Recall and how to determine if you have one?
Things to Consider When Recalling Your Medical
Device Adverse Consequences or Risk to
Health Who can initiate a Medical Device
Recall? Where and What Should Be Reported?
Reports of Corrections and Removals Companys
Responsibilities for a Recall Companys Recall
Communications, Strategy and follow-up
responsibilities Quality Control Program
Recall List Recall Status Reports Recall
Termination FDA Compliance policy guides
FDAs Role and Expectations
Compliance Global Inc 2015
www.ComplianceGlobal.us
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Upcoming Webinar of
Larry Spears Effective Strategy for Medical
Device Recalls. Tuesday , August 18th 0100 PM
EST Learning Objective How to identify,
initiate, and manage a recall action
effectively What FDA requires for recall
reporting How FDA classifies and monitors
recalls What authority FDA can use to force a
recall and ensure it is managed effectively Who
Will Benefit Regulatory Affairs Managers /
Senior Directors Quality Assurance Managers /
Senior Directors Clinical Research Managers /
Senior Directors Data Management Personnel
Compliance Global Inc 2015
www.ComplianceGlobal.us
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Upcoming Webinar of Larry Spears Effective
Strategy for Medical Device Recalls. Tuesday ,
August 18th 0100 PM EST Level Beginner
Speaker profile Larry Spears has deep regulatory
expertise from over 35 yearsâ experience in
government and consulting. This includes
investigations, compliance and regulatory roles
with FDA including senior compliance leadership
positions in the CDRH Office of Compliance, as a
consultant with a large life sciences consulting
firm and as an independent consultant. Mr. Spears
provides global regulatory strategy consultation
to Life Science companies primarily in medical
devices/diagnostics and pharmaceuticals with a
focus on quality systems gap assessments, FDA
mock inspections, quality system development and
planning, and remediation for FDA inspection
findings including, CAPA and complaints, design
controls, supplier controls, production
management, and training.
Compliance Global Inc 2015
www.ComplianceGlobal.us
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For more information...www.ComplianceGlobal.us
Or contact us at Toll Free 1-844-746-4244
Tel1-516-900-5515Fax 1-516-900-5510 Email
support_at_complianceglobal.us
Compliance Global Inc 2015
www.ComplianceGlobal.us
