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:71714 DTSTAMP:20260905T081925Z SUMMARY:Applying U.S. FDA Laws and Regulations 2017 DESCRIPTION: \nCourse \"Applying U.S. FDA Laws and Regulations to Eac h Phase of Total Product Life Cycle (TPLC)\" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC rece rtification upon full completion.\nOverview:\nThis workshop style trai ning course is supported by comprehensive knowledge of U.S. FDA laws a nd regulations and 30 year of extensive experience working within in t he U.S. FDA regulated industries. In these 2 days, the following essen tial topics will be covered:\n\nTotal Product Life Cycle and Your Medi cal Device\nAn Overview of U.S. FDA Medical Device Regulation\nRegulat ions for Design and Product Development\nPremarket Notification - 510( k) and Premarket Approval (PMA)\nRegulations for Production & Process Control\nReadiness for FDA Facility Inspection\n\nWhy should you atten d?\nThe complex network of multilayer laws, regulations and regulatory requirements create confusion and misinterpretation that leads the de vice manufacturer into Non-compliance state. Non-compliance to applica ble laws and regulations results into severe penalties or regulatory a ctions form U.S. FDA that could damage image and position of the compa ny. To avoid such undesired circumstances, it is important to see a bi g picture of TPLC and all applicable U.S. FDA laws and regulation at e ach phase of their own product life cycle.\nAreas Covered in the Sessi on:\n\nAn Overview of U.S. FDA Regulation for Medical Devices\nQuality System Regulation 21 CFR 820: Current GMP for Medical devices\nPremar ket Notification - 510(k) and Premarket Approval (PMA)\nPost Market Re porting Requirements\nFDA Facility Inspection\n\nWho will benefit:\n\n Regulatory Affairs - VP, Director and Managers\nRegulatory Affairs - A ssociates and Specialists\nCompliance Officers\nResearch & Development - Product Managers\nQuality Assurance and Quality Engineers\n\n\n \n Location: SFO, CA Date: March 2nd & 3rd, 2017 and Time: 08:30 AM to 5 :00 PM\n \nVenue: DoubleTree by Hilton Hotel San Francisco Airport\nA ddress: 835 Airport Blvd., Burlingame CA 94010-9949\n \nPrice:\n \nP rice: $1,295.00\nUntil January 20, Early Bird Price: $1,295.00 From Ja nuary 21 to February 28, Regular Price: $1,495.00\n \nRegister for 5 attendees   Price: $3,885.00       $6,475.00 You Save: $2,590. 00 (40%)*\nUntil January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00\nRegister now and save $2 00. (Early Bird)\n \nQuick Contact:\nNetZealous DBA as GlobalComplia ncePanel\n \nPhone: 1-800-447-9407\nFax: 302-288-6884\nEmail: support @globalcompliancepanel.com      \n\n\nFor more information visit https://medtechiq.ning.com/events/applying-u-s-fda-laws-and-regulation s-2017 DTSTART;TZID=America/New_York:20170302T083000 DTEND;TZID=America/New_York:20170303T170000 CATEGORIES:compliance, training, and, latest, information LOCATION:SFO, CA WEBSITE:http://www.globalcompliancepanel.com/control/globalseminars/~p roduct_id=900774SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_ March_2017_SEO URL:http://www.globalcompliancepanel.com/control/globalseminars/~produ ct_id=900774SEMINAR?channel=mailer&camp=Seminar&AdGroup=medtechiq_Marc h_2017_SEO CONTACT:8004479407 ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo binson ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562015008?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR