This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. ........

Date : 27th April 2017 to 28th April 2017

Place : United States, Raleigh

Website :http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900766SEMINAR?channel=mailer&camp=Seminar&AdGroup=allconferencealerts_April_2017_SEO

Contact Person:John Robinson

Description:

This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. ........

This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. ........ will be held in Raleigh,United States on date 2017-04-28

---

Deadline for abstracts/proposals : 25th April 2017

Keynote Speakers : Dan O'Leary, President, Ombu Enterprises , 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 Biomedica

Conference Highlights : Agenda: Lecture 1: Overview of ISO 13485:2016 • Summary of the differences between ISO 13485:2003 and ISO 13485:2016 • High level comparison with FDA QSR Lecture 2: Regulatory Framework • Transition period for certificates • Canada - MDSAP v CMDCAS • EN ISO 13485:2016 and the MDD • The new QMS audit findings/nonconformance grading system • Implications of the EU's Medical Device Regulations Lecture 3: Management Responsibility • Quality Policy and Objectives

Venue :Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States

Check the event website for more details.