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Implementing ISO 2017 Boston

Thu, November 16 - Fri, November 17, 2017 Boston, Massachusetts
Embassy Suites by Hilton Boston at Logan Airport 207 Porter St Boston, Massachusetts 02128 United States +1 617-567-5000

About Implementing ISO 2017 Boston

IMPLEMENTING ISO, BOSTON, NOVEMBER 16-17, 2017

The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.

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. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system. However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

The workshop covers implications in particular regulatory systems including MDASP and its nonconformity grading system.

This event will take place at Embassy Suites by Hilton Boston at Logan Airport, 207 Porter St, Boston, Massachusetts.

Who Will Benefit:

  • Quality managers
  • Management Representatives
  • Quality engineers
  • Quality assurance and quality control
  • Regulatory affairs managers
  • Regulatory affairs professionals
  • R&D managers
  • R&D engineers
  • Product design and development
  • Operations managers
  • Production managers and supervisors
  • Manufacturing engineers
  • Risk managers
  • Complaint system team members
  • CAPA team members

Why should you attend:

The transition to ISO 13485:2016 can be complicated and, for some companies, the period is short, depending on when the current certificate expires. Start planning and implementing as soon as possible. This workshop provides the knowledge and understanding to update your QMS.

Workshop Objectives:

Participants will learn the major changes in the new version of the standard. In addition, they will understand where the new standard and QSR do not agree. The primary objective is to give participants the understanding needed for an efficient and effective QMS update.

About Implementing ISO 13485:2016

Implementing ISO 13485:2016, January 26-27, 2017:

What is this event?

Implementing ISO 13485:2016 workshop offers practical implementation advice to update your QMS. The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation.

At event the final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS).

Where is this event located?

This event will take place at Hilton Garden Inn Phoenix Midtown, 4000 N Central Ave, Phoenix, Arizona, USA.

Who should attend this event?

This event is designed for Quality managers, Management Representatives, Quality engineers, Regulatory affairs managers, Regulatory affairs professionals, Product design and development, Production managers and supervisors and Manufacturing engineers.

What are some highlights of this event?

Event Highlights:

  • Overview of ISO 13485:2016
  • Management Responsibility
  • Resource Management
  • Design and Development
  • Supplier Management
  • Production Processes
  • Monitoring and Measuring

Speaker:

Dan O'Leary

Why should I attend this event?

  • Attendee will learn the major changes in the new version of the standard.
  • You will understand where the new standard and QSR do not agree.
  • You will get the knowledge and understanding to update your QMS.

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