FDAnews Announces Complaint Handling and Medical Device Reporting: Where Inspectors Look First, On-Demand Webinar, Sept. 25, 2014

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Devicemakers can take the mystery out of complaint handling and MDR by attending the Complaint Handling and Medical Device Reporting On-Demand webinar. The presenter, noted legal expert Michael Heyl, has developed a compliance roadmap that saves time, money and headaches for device manufacturing companies.

FDAnews

FDAnews

“Inclusion of real world warning letters to show what the FDA is looking for in an MDR program”--Webinar Attendee

Complaint Handling and Medical Device Reporting:
Where Inspectors Look First
**FDAnews On-Demand Webinar**
Sept. 25, 2014 ● Any Time at Your Convenience
http://www.fdanews.com/MDComplaintHandlingOnDemand

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

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

Here’s what 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. Devicemakers 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.

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

In 90 fast-paced minutes, attendees will gain a clear understand of what FDA investigators look for when evaluating complaint handling and medical device reporting programs.

Attendees will discover what the FDA inspectors look for when they enter the facility, plus:

  •     Understand when an event or field action is a complaint and when not.
  •     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
  •     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. Attendees may listen to the recording at their convenience on Sept. 25.

Who Will Benefit:
Here’s a suggested list of potential participants:

  •     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

Meet the Instructor:
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.

Conference Details:
Complaint Handling and Medical Device Reporting:
Where Inspectors Look First
**FDAnews On-Demand Webinar**
Sept. 25, 2014 ● Any Time at Your Convenience
http://www.fdanews.com/MDComplaintHandlingOnDemand

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/MDComplaintHandlingOnDemand
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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