Implementing ISO 13485:2016 (NTZ)
At
Courtyard Arlington Crystal City/Reagan National Airport
For more information: https://www.eventbrite.com/e/implementing-iso-134852016-ntz-tickets-42982991284?aff=RMV
DESCRIPTION
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Implementing ISO 13485:2016
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 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.
Why should you attend:
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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.
For more information: https://www.eventbrite.com/e/implementing-iso-134852016-ntz-tickets-42982991284?aff=RMV
Workshop Objectives:
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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.
Who Will Benefit:
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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
SPEAKER
Dan O'Leary
President, Ombu Enterprises
Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/implementing-iso-134852016-ntz-tickets-42982991284?aff=RMV
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