RAPS Approved Webinar on
Implementing Medical Device Complaint Handling Systems
Date: Tuesday, November 13, 2012 Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Course "Implementing Medical Device Complaint
Handling Systems" has been pre-approved by RAPS Instructor: David Lim
as eligible for up to 1.00 credits towards a Location: Online
participant's RAC recertification upon full completion. Price : $245.00 (for one participant)
Chairman and CEO, Register Now
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.” Since then, Dr. Lim has held various positions at Duke,
US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A
Luminex Company. In 2009, ...more
This webinar is intended to demonstrate how to implement medical device complaint handling
All medical device manufacturers are required to comply with the complaint handling requirements.
Understanding the relevant and applicable requirement can significantly contribute to achieving
compliance and remaining compliant, resulting in saving significant amount of time and efforts in
business while ensuring the safety and effectiveness of the medical device products. This webinar
will discuss how to implement medical device complaint handling procedures, how to achieve
compliance, and how to remain compliant.
At the end of the webinar, you will get familiarized with the system for handling all types of medical
Areas Covered in the Session:
l Overview and review of the applicable statutes and
l What to do when complaints are received?
l How to process complaints.
l What processes need to be in place?
l When to investigate complaints.
l When to open a CAPA(s).
l Contents of records of investigation.
l Enforcement actions: numerous case studies
l Lessons learned
Who Will Benefit:
l VPs Suggest a Topic
l Compliance officers
l Attorneys More Webinars
l Complaint handling
l Clinical affairs
l Regulatory affairs
l Quality assurance Click here to
l R&D register for this
l CROs webinar
It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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