Summary:A RAPS pre-approved webinar on the topic, €Implementing Medical Device Complaint Handling Systems€, is being organized on November 13 by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider.This webinarearns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion, and will have Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), as the speaker.
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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:
o Overview and review of the applicable statutes and regulations
o Definitions
o What to do when complaints are received?
o How to process complaints
o What processes need to be in place?
o When to investigate complaints
o When to open a CAPA(s)
o Contents of records of investigation
o Enforcement actions: numerous case studies
o Lessons 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 FDA's 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
o CEOs
o VPs
o Compliance officers
o Attorneys
o Complaint handling personnel
o Clinical affairs
o Regulatory affairs
o Quality assurance
o R&D
o CROs
o Consultants
o Contractors/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
SITE URL