BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:72232
DTSTAMP:20260515T151745Z
SUMMARY:Implementing ISO 13485:2016- 2017 by Dan O'Leary
DESCRIPTION:\nOverview:\nThe final version of ISO 13485:2016 is now av
 ailable and companies should be planning their implementation. There a
 re significant changes from the earlier version; they will require maj
 or modifications to the Quality Management System (QMS). The new versi
 on has better alignment with FDA's QSR, but there are still major diff
 erences that create issues for effective QMS implementation.\nThis wor
 kshop covers the differences from the 2003 version to the 2016 version
  and offers practical implementation advice to update your QMS. Partic
 ipants will also learn the differences with QSR and understand how to 
 resolve them. The workshop uses extensive examples and exercises to he
 lp clarify the concerns.\nSome regulatory systems will rely on ISO 134
 85:2016 through the Medical Device Single Audit Program (MDSAP). The U
 S will participate in MDSAP, but doesn't expect to change its regulati
 ons. The EU is not participating, has published its own version, EN IS
 O 13485:2016, and will continue with the Notified Body system. However
 , the EU intends to replace the directives with new regulations result
 ing in new versions of EN ISO 13485:2016 and EN ISO 14971:2012.\nThe w
 orkshop covers implications in particular regulatory systems including
  MDASP and its nonconformity grading system.\n \nWhy should you atten
 d :\nThe transition to ISO 13485:2016 can be complicated and, for some
  companies, the period is short, depending on when the current certifi
 cate expires. Start planning and implementing as soon as possible. Thi
 s workshop provides the knowledge and understanding to update your QMS
 .\nWorkshop Objectives::\nParticipants will learn the major changes in
  the new version of the standard. In addition, they will understand wh
 ere the new standard and QSR do not agree. The primary objective is to
  give participants the understanding needed for an efficient and effec
 tive QMS\n \n\nLocation: Raleigh, NC Date: April 27th & 28th, 2017 a
 nd Time: 9:00 AM to 6:00 PM\n \n \nVenue: Courtyard Raleigh-Durham A
 irport\nAddress:  2001 Hospitality Ct, Morrisville, NC 27560, United 
 States\n \nPrice:\n \nRegister now and save $200. (Early Bird)\n \n
 Price: $1,295.00 (Seminar Fee for One Delegate)\n \nUntil March 20, E
 arly Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $
 1,495.00\nRegister for 5 attendees   Price: $3,885.00 $6,475.00 You 
 Save: $2,590.00 (40%)*\n \n \nQuick Contact:\nNetZealous DBA as Glob
 alCompliancePanel\n \nPhone: 1-800-447-9407\nFax: 302-288-6884\nEmail
 : support@globalcompliancepanel.com               \n\nFo
 llow us on LinkedIn: https://www.linkedin.com/company/globalcompliance
 panel?\nLike us our Facebook page: https://www.facebook.com/TrainingsA
 tGlobalCompliancePanel/\nFollow us on Twitter: https://twitter.com/GCP
 anel\n \n\nFor more information visit https://medtechiq.ning.com/even
 ts/implementing-iso-13485-2016-2017-by-dan-o-leary
DTSTART;TZID=America/New_York:20170427T080000
DTEND;TZID=America/New_York:20170427T180000
CATEGORIES:implementing, iso, "13485:2016-", 2017, by, dan, "o'leary"
LOCATION:Raleigh, NC
WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p
 roduct_id=900766SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_
 April_2017_SEO
URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ
 ct_id=900766SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_Apri
 l_2017_SEO
CONTACT:800-447-9407
ORGANIZER:NetZealous DBA as GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562015186?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
END:VEVENT
END:VCALENDAR