Live web seminar Understanding and Implementing the EU Vigilance System
View: 212
Website https://compliance2go.com/product/?topic=understanding-and-implementing-the-eu-vigilance-system |
Edit Freely
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
DESCRIPTIONHave 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 seminarAn overview of the EU Vigilance SystemThe role of MEDDEV documents in the EU systemThe conditions that require an EU adverse event reportThe timing of adverse event reports, including their classificationDeveloping Periodic Summary Reports to help reduce the quantity of reportsTrending of complaints and required reporting after recognizing a “signal”The two elements of recalls ? the Field Safety Corrective Action (FSCA) and the FieldSafety Notice (FSN)Who will benefitRegulatory ManagersManagement RepresentativesQuality ManagersCompliance ManagersNotified Body LiaisonAudit ManagersComplaint and Incident SpecialistsWhy you should attendThis webinar provides the understanding and tools you need to for an effective QMS implementation. Webinar includesQ/A Session with the Expert to ask your questionA checklist of Steps to implement the vigilance systemPDF print only copy of PowerPoint slides90 Minutes Live Presentation
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.