Time: August 17, 2017 at 9am to August 18, 2017 at 6pm
Location: Four Points by Sheraton Chicago O'Hare
Street: 10249 W Irving Park Road, Schiller Park, IL 60176, United States
City/Town: Chicago, IL
Website or Map: http://www.globalcompliancepa…
Phone: Event Manager
Event Type: online, healthcare, training, courses
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Jun 12, 2017
Course "Implementing ISO 13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Venue: Four Points by Sheraton Chicago O'Hare 10249 W Irving Park Road, Schiller Park, IL 60176, United States
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until July 10, Early Bird Price: $1,295.00 From july 11 to August 15, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
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