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2-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls” in Phoenix

Course "Effective Complaint Handling, Medical Device Reporting and Recalls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

27 28 February 2014

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An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up.

1 speaker

2 sessions

Day 1 from 9am to 6pm Thursday 27th February 2014

Day 2 from 9am to 6pm Friday 28th February 2014

Hilton Garden Inn Phoenix Midtown

United States United States / Phoenix

4000 N. Central Avenue, Phoenix, Arizona, 85012, USA, 85012

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2 known attendees

  • GlobalCompliancePanel
  • David R. Dills

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