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DTSTART:19700308T020000
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UID:2140535:Event:60593
DTSTAMP:20260905T114814Z
SUMMARY:The DHF, Technical File and Design Dossier - Similarities, Dif
 ferences and The Future
DESCRIPTION:Overview:\nOne of our most popular subjects, continuously 
 updated with the latest U.S. FDA and European Union requirements. As U
 .S. companies go global, they must meet different product design docum
 entation. The U.S. FDA's CGMPs mandate Design Control and the Design H
 istory File (DHF) at 21 CFR 820.30. In order to sell globally, the EU'
 s CE-marking documentation is a requirement -- the Technical FiIe or D
 esign Dossier, as described in their Medical Device Directive. What ar
 e the requirements for each file. Currently they serve different purpo
 ses, support different goals, but the TF/DD is moving in the direction
  of the DHF.\nWho Will Benefit:\nThis workshop will provide valuable a
 ssistance to all regulated companies that need to implement, review an
 d/or modify their Device History Files, Device Master Records, Device 
 History Records, Technical Files / Design Dossiers, documents, activit
 ies / plan(s). This information addresses Medical Device documentation
  requirements and implementation. The employees who will benefit inclu
 de:\n\nSenior and middle management and staff\nRegulatory Affairs\nQA/
 QC\nR&D\nProduction Management\nManufacturing Engineers\nProcess Engin
 eers\nProject Managers\nVendors, sales and marketing\nAny tasked with 
 medical device development, documentation, and regulatory responsibili
 ties\n\nSpeaker Profile:\nJohn E. Lincoln, is Principal of J. E. Linc
 oln and Associates LLC, a consulting company with over 31 years experi
 ence in U.S. FDA-regulated industries, 17 of which as a full-time cons
 ultant. John has worked with companies from start-up to Fortune 100, i
 n the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
  He specializes in quality assurance, regulatory affairs, QMS problem 
 remediation and FDA responses, new / changed product 510(k)s, process 
 / product / equipment V&V including QMS and software validations, ISO 
 14971 product risk management files / reports, Design Control / Design
  History Files, Technical Files. \nDate, Venue & Price:\nHeld 12-13 S
 eptember 2013 Los Vegas, Nevada, USA.\nVenue: Hilton Grand Vacations 
 Suites at the Flamingon\nAddress: 3575 Las Vegas Boulevard South, Las
  Vegas, Nevada, 89109-4313, USA\n\nPrice: $1,295.00\nRegister now and
  save $200. (Early Bird) Until July 31, Early Bird Price: $1,295.00  
 from August 01 to September 10, Regular Price: $1,495.00\n \nContact 
 Information:  Event Coordinator\nToll free: 1800 447 9407\nFax: 302 28
 8 6884\nEmail: support@globalcompliancepanel.com\nWebsite: https://www
 .globalcompliancepanel.com\nLIVE CHAT SUPPORT ALSO - http://www.global
 compliancepanel.com/chat/client.php\nGlobalCompliancePanel\nNetZealous
  LLC\n161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA\nFor M
 ore Info Click Here: http://bit.ly/13kjHpW\n\nFor more information vis
 it https://medtechiq.ning.com/events/the-dhf-technical-file-and-design
 -dossier-similarities
DTSTART;TZID=America/New_York:20130912T090000
DTEND;TZID=America/New_York:20130913T180000
CATEGORIES:conference
LOCATION:United States
WEBSITE:
URL:
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/2562006624?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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