Raps Pre-approved Webinar On implementing Medical Device Complaint Handling Systems

Description:

Description:

Being able to handle complaints is one of the requirements that FDA has set out for medical device companies. So, medical device companies will have to put complaint handling systems in place. This webinar is about how to do this.

Since complying with complaint handling is a regulatory requirement from the FDA; medical device companies need to put such a mechanism in place. Having a compliant complaint handling system means savings of significant amounts of time and resources. Having a complaint handling system also enables firms to concentrate on their core business and improve the effectiveness of their products.

Areas covered in this session:

oOverview and review of the applicable statutes and regulations

oDefinitions

oWhat to do when complaints are received?

oHow to process complaints

oWhat processes need to be in place?

oWhen to investigate complaints

oWhen to open a CAPA(s)

oContents of records of investigation

oEnforcement actions: numerous case studies

oLessons learned

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When:November 13,10:00 AM PDT | 01:00 PM EDT

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By whom:

Dr. David Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal, Science.

Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products).

In 2009, Dr. Lim served as a member during the FDAs Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail.

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For whom:

The webinar will benefit

oCEOs

oVPs

oCompliance officers

oAttorneys

oComplaint handling personnel

oClinical affairs

oRegulatory affairs

oQuality assurance

oR&D

oCROs

oConsultants

oContractors/subcontractors

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Duration: 60 minutes

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To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407

ARTICLE LINK

by: GlobalCompliancePanel

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