FDAnews Announces — Device Complaint Management: Pass Inspection Without Getting a 483 Webinar, Oct. 13, 2015

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Complaint management systems have long been an easy target for FDA inspectors. But that does not have to be the case if the four major elements are included in the device complaint management system.

Device Complaint Management:
Pass Inspection Without Getting a 483
**FDAnews Webinar**
Oct. 13, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/devicecomplaintmanagement

Complaint management systems have long been an easy target for FDA inspectors.
Come up short in an inspection and the FDA can issue a Form 483 or a warning letter.

But that does not have to be the case if the four major elements are included in the device complaint management system:

  •     Receiving, documenting, and investigating complaints;
  •     Determining when complaints are reportable to the FDA;
  •     Analyzing complaints to detect recurring quality problems;
  •     Updating the risk management file.

Using FDA sources such as regulations, the QSR preamble and inspection techniques, industry expert Dan O’Leary will explain each of those topics and show how they link together while providing advice on effective implementation.
This webinar provides the practical information needed so that the device complaint management system passes an FDA inspection without a 483. In 90 minutes attendees will learn:

  •     The definition of a complaint and issues that are not medical device complaints
  •     The difference between complaint evaluation and complaint investigation
  •     The conditions that require an investigation and the associated records
  •     Determining reportability as an MDR
  •     Linking individual complaints to the risk management file
  •     Complaint analysis to determine quality problems
  •     Linking complaint analysis results to the risk management file

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:

  •     Quality Assurance Managers
  •     Regulatory Affairs Managers
  •     Complaint Unit Managers
  •     Quality Data Analysts
  •     Risk Managers
  •     MDR Managers and Specialists

Conference Details:
Device Complaint Management:
Pass Inspection Without Getting a 483
**FDAnews Webinar**
Oct. 13, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/devicecomplaintmanagement

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/devicecomplaintmanagement
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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