Understanding and Implementing the EU Vigilance System

Instructor: Daniel O Leary
Product ID: 704205
  • Duration: 90 Min
This training program will furnish attendees with an overview of the EU vigilance system and the understanding and tools necessary for effective QMS implementation. It will also provide an implementation checklist for the vigilance system.

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2015

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Why Should You Attend:

Have you fully implemented the current version of the EU’s vigilance system? Your Notified Body will check at the next audit. The requirements are extensive and even though the current version became effective in July 2013, many device manufacturers still have gaps. The problem is compounded for device manufacturers that serve the US market, because the requirements are not harmonized.

One major difference is the concept of indirect harm, where devices do not act directly on the individual. This has specific application to in-vitro diagnostic (IVD) and other devices. The changes that resulted in the current version include in-vitro fertilization (IVF) and assisted reproductive technologies (ART) devices.

The vigilance document is extensive, covering adverse events, recalls, and complaint analysis. This means the device manufacturer needs to implement a comprehensive approach that will cover many elements of the Quality Management System (QMS).

Understanding the many elements in the vigilance document will help you create an effective QMS – one that will stand up to a Notified Body audit. But to do this you need to recognize all of the elements in the document. In addition, they won’t line up nicely with the corresponding US or Canadian regulations.

This webinar will provide the information you need to understand the vigilance document. It explains the various requirement including adverse event reporting, recall notification to regulators, recall notification to customers, trending analysis for complaints, and other areas covered.

Areas Covered in the Webinar:

  • An overview of the EU vigilance system
  • The role of MEDDEV documents in the EU system
  • The conditions that require an EU adverse event report
  • The timing of adverse event reports, including their classification
  • Developing periodic summary reports to help reduce the quantity of reports
  • Trending of complaints and required reporting after recognizing a signal
  • The two elements of recalls – the Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)

Who Will Benefit:

  • Regulatory Managers
  • Management Representatives
  • Quality Managers
  • Compliance Managers
  • Notified Body Liaison
  • Audit Managers
  • Complaint and Incident Specialists

Instructor Profile:

Daniel O'Leary is 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. Mr. O'Leary 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 Master’s Degree in Mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and certified by APICS in resource management.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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