Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting - Webinar CD/Transcript

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Complaint Handling and Medical Device Reporting: Where Inspectors Look First

When devices displease customers, they complain. How you respond is another matter. Tired of FDA sanctions for complaint-handling glitches? Read on ...

When it comes to getting in trouble with the FDA, devicemakers’ customers are their biggest headache.

Year in and year out, at least 65% of warning letters include citations for complaint handling. In 2012, complaint management violations topped the list for device companies — a whopping 105 warning letters cited CFR 820.198.

A deeper analysis shows exactly what FDA is looking for — and often finds:

  • Poor procedures, or failing to follow procedures, to receive, review and evaluate complaints
  • Failing to close out product complaints on time
  • A disconnect between complaints with MDR regulatory requirements

And the challenges are heating up. In summer, the agency issued a draft guidance telling devicemakers seeking additional information about MDR reportable events to base the degree of their efforts on the nature and severity of the report. Lack of a returned device is no excuse, the FDA said.

You can take the mystery out of complaint handling and MDR. Order the webinar CD and transcript for Complaint Handling and Medical Device Reporting: Where Inspectors Look First today.

Your presenter, noted legal expert Michael Heyl, has developed a compliance roadmap that saves time, money and headaches for device manufacturing companies like yours.

In 90 fast-paced minutes, you gain a clear understand of what FDA inspectors look for when evaluating complaint handling and medical device reporting programs.  A short quiz helps you understand where you need help … and where you’re doing things right.

You’ll discover what the FDA inspectors look for when they enter your shop, plus:

  • Understand when an event or field action is a complaint and when not. (The differences may surprise you.)
  • Discover how to handle complex, potentially dangerous MDR events
  • Learn to prepare service reports that meet FDA expectations
  • Find methods to train personnel to record, track and trend complaints
  • Teach staff when complaints meet the threshold for reportable events and how to escalate them properly
  • Examine trends that anticipate tomorrow's FDA inspection focus
  • Test your knowledge with a quiz that will show you where you've got it right — and where you need to improve your complaint handling program
  • And much more

This webinar CD and transcript comes along at just the right moment. In July, the FDA released a draft guidance, Medical Device Reporting for Manufacturers, that when final will replace its March 1997 guidance of the same name. In the new draft guidance, the FDA expects firms to focus more closely on complaint investigations and better understand and report device-related adverse reports.

Customer complaints will never go away. It’s worth 90 minutes to discover the right way to handle them. What are you waiting for?

  • Medical device manufacturing and executives
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Quality inspection and test managers
  • Supply chain specialists
  • Process development staff
  • Compliance officers
  • Training managers
  • Regulatory affairs and compliance professionals

Mike Heyl, an attorney with Hogan Lovell, specializes in post-market compliance and enforcement in the medical device sector, including the FDA’s Quality System Regulation (QSR), adverse event reporting and field action requirements. In addition, he helps conduct internal investigation where companies are accused of alleged regulatory violations; reviews and drafts standard operating procedures; assists with import and export issues; conducts regulatory due diligence; negotiates corporate mergers and acquisitions and initial public offerings; creates and implements corrective action plans, and provides wide-ranging advice on device-related regulatory issues.