Live web seminar Understanding and Implementing the EU Vigilance System

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Category Medical Device

Deadline: June 21, 2015 | Date: June 22, 2015

Venue/Country: Online, U.S.A

Updated: 2015-05-29 14:51:36 (GMT+9)

Call For Papers - CFP

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 that 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 provides 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 seminar

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

Why you should attend

This webinar provides the understanding and tools you need to for an effective QMS implementation.

Webinar includes

Q/A Session with the Expert to ask your question

A checklist of Steps to implement the vigilance system

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation