Implementing ISO 13485:2016 (NTZ)<br />At<br />Courtyard Arlington Crystal City/Reagan National Airport<br />For more information: https://www.eventbrite.com/e/implementing-iso-134852016-ntz-tickets-42982991284?aff=RMV<br /><br /><br />DESCRIPTION<br />============<br />Implementing ISO 13485:2016<br /><br />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). <br />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.<br /><br /><br />Why should you attend:<br />=========================<br />The transition to ISO 13485:2016 can be complicated and, for some companies, the period is short, depending on when the current certificate expires. <br />Start planning and implementing as soon as possible. This workshop provides the knowledge and understanding to update your QMS.<br /><br /><br />For more information: https://www.eventbrite.com/e/implementing-iso-134852016-ntz-tickets-42982991284?aff=RMV<br /><br />Workshop Objectives:<br />==========================<br />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. <br />The primary objective is to give participants the understanding needed for an efficient and effective QMS update.<br /><br /><br /><br />Who Will Benefit:<br />=====================<br />Quality managers<br />Management Representatives<br />Quality engineers<br />Quality assurance and quality control<br />Regulatory affairs managers<br />Regulatory affairs professionals<br />R&D managers<br />R&D engineers<br />Product design and development<br />Operations managers<br />Production managers and supervisors<br />Manufacturing engineers<br />Risk managers<br />Complaint system team members<br />CAPA team members<br /><br /><br />SPEAKER<br /><br />Dan O'Leary<br />President, Ombu Enterprises <br /><br /><br />Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence<br /><br />Please contact the event manager Marilyn below for the following:<br />- Discounts for registering 5 or more participants.<br />- If your company requires a price quotation.<br />Event Manager Contact: marilyn.b.turner(at)nyeventslist.com<br />You can also contact us if you require a visa invitation letter, after ticket purchase.<br />We can also provide a certificate of completion for this event if required.<br />----------------------------------<br /><br />For more information: https://www.eventbrite.com/e/implementing-iso-134852016-ntz-tickets-42982991284?aff=RMV<br /><br />Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675<br />Twitter: https://twitter.com/nyeventslist<br />Facebook: https://www.facebook.com/NewYorkEventsList<br />New York Events List: http://nyeventslist.com/