FDAnews Announces — Detecting Trends in Medical Device Complaints Webinar, May 18, 2017

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When device users complain, those complaints must be passed on – to the FDA, the EU and other regulators. Learn the trend analysis method the EU Vigilance system recommends ... master classification systems including definition of a complaint, an ISO standard for coding adverse events, FDA coding for MDRS and coding derived from risk management files ... and, as a special bonus, receive a technical description of analysis methods that includes guidance on their use.

Detecting Trends in Medical Device Complaints
**An FDAnews Webinar**
May 18, 2017 — 1:30 p.m. – 3:00 p.m. ET

Medical device users complain. Manufacturers respond. But that’s not the end of the story.

Investigators will check complaint reports during on-site visits.

Mastering complaint reporting takes effort and attention. Guidance would be welcome.

So here’s a timely new webinar from FDAnews to answer all complaint-reporting questions.

In just 90 information-packed minutes, Dan O’Leary of Ombu Enterprises LLC clarifies complex and confusing rules and formats that govern device complaint reporting. Attendees will discover:

  •     Systems in use for analyzing, classifying and counting complaints
  •     FDA-specific coding for MDRs
  •     An ISO standard on coding adverse events
  •     Coding derived from risk management files
  •     EU-specific requirements for trend reporting
  •     The method from the GHTF guidance document
  •     Linking complaints, coding, and risk management
  •     Using trending information for corrective and preventive action
  •     And much more!

Bonus Material! Participants receive a technical description of analysis methods plus guidance on their use.

Complaint management is essential to a functioning quality management system. Understanding the FDA’s QSR isn’t enough; manufacturers must also master ISO 13485:2016 and the new EU-MDR.

Meet the Presenter:
Dan O’Leary, a favorite presenter [link to testimonials box] at dozens of FDAnews-sponsored workshops. Mr. O’Leary boasts 30+ years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. His consultancy, Ombu Enterprises LLC, focuses on operational excellence and regulatory compliance particularly for small manufacturing companies. He 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:
People in the following roles can especially benefit from this presentation:

  •     Quality Managers
  •     Quality Engineers
  •     Quality Data Analysts
  •     Regulatory Managers
  •     Complaint Specialists
  •     Risk Management Specialists

Webinar Details:
Detecting Trends in Medical Device Complaints
**An FDAnews Webinar**
May 18, 2017 — 1:30 p.m. – 3:00 p.m. ET

$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/mdcomplaints                                                                
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
+1 (703) 538-7665
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