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:72236 DTSTAMP:20260524T231127Z SUMMARY:Preparing Premarket Submissions that secures U.S. FDA Clearanc es/Approvals 2017 DESCRIPTION:\nOverview:\nThis workshop style training course is design ed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device com panies. In these 2 days, the following essential elements of U.S FDA p remarket submissions will be covered:\n\nHistory and background of U.S FDA Laws and Regulations\nClassify Your Device\nChoose the Correct Pr emarket Submission for your device\nCompile the Appropriate Informatio n for your Premarket Submission\nAuthor and Prepare your Premarket Sub mission\nSubmit your Premarket Submission to the FDA\nInteract with FD A Staff during Review and Approval\nComplete the Establishment Registr ation and Device Listing\n\n \nWhy should you attend :\nThe U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is co nsidered a most stringent and complex. Only a good knowledge of U.S. F DA laws, regulations, and requirements is not sufficient to win a clea rance/approval. You are required a proper training on how to set and s tate regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you t hrough building process of a reader's friendly but resounding premarke t submission and also give you tips and suggestions on how to work eff ectively with the U.S. FDA officials during review and approval proces s of your submission.\n\n \nLocation: Raleigh, NC Date: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM\n \nVenue: Courtyard Raleigh -Durham Airport\nAddress:  2001 Hospitality Ct, Morrisville, NC 27560 , United States\n \nPrice:\n \nRegister now and save $200. (Early Bi rd)\n \nPrice: $1,295.00 (Seminar Fee for One Delegate)\n \nUntil Ma rch 20, Early Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $1,495.00\nRegister for 5 attendees   Price: $3,885.00 $6,47 5.00 You Save: $2,590.00 (40%)*\n \n \nQuick Contact:\nNetZealous DB A as GlobalCompliancePanel\n \nPhone: 1-800-447-9407\nFax: 302-288-68 84\nEmail: support@globalcompliancepanel.com     \n\nFollow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel?\nLik e us our Facebook page: https://www.facebook.com/TrainingsAtGlobalComp liancePanel/\nFollow us on Twitter: https://twitter.com/GCPanel\n \n  \n \n \n \n\nFor more information visit https://medtechiq.ning.com /events/preparing-premarket-submissions-that-secures-u-s-fda-clearance s DTSTART;TZID=America/New_York:20170427T090000 DTEND;TZID=America/New_York:20170428T180000 CATEGORIES:preparing, premarket, submissions, that, secures, "u.s.", f da, "clearances/approvals", 2017 LOCATION:San Diego, CA WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=900778SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_ April_2017_SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=900778SEMINAR?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/2562015194?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR