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?

Mark your calendar for Thursday, Sept. 25, for On-Demand access to Michael Heyl’s immensely popular webinar on complaint handling.

Here’s what our satisfied registrants had to say on what they liked about this webinar:

• “It was a good pace. It covered a lot of material. It gave specific examples.”
• “Inclusion of real world warning letters to show what the FDA is looking for in an MDR program”

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.  For the last few years complaint management was near the top of FDA’s most commonly cited list. In some years more than 100 Warning Letters citing CFR 820.198 violations were issued.

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.  You can take the mystery out of complaint handling and MDR. Sign up today for FDAnews’ on-demand webinar, Complaint Handling and Medical Device Reporting: Where Inspectors Look First.

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’ll gain a clear understand of what FDA investigators 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
  

Customer complaints will never go away. It’s worth 90 minutes to discover the right way to handle them.

Please note; this webinar has been previously recorded and no questions will be taken during the presentation. You may listen to the recording at your convenience on Sept. 25.

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