Overview:One 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 documentation. The U.S. FDA's CGMPs mandate Design Control and the Design History 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 Design Dossier, as described in their Medical Device Directive. What are the requirements for each file. Who Will Benefit:Senior and middle management and staffRegulatory AffairsQA/QCR&DProduction ManagementManufacturing EngineersProcess EngineersProject ManagersVendors, sales and marketingAny tasked with medical device development, documentation, and regulatory responsibilitiesCourse Outline:Day 1 - AgendaLecture 1: The Design Control requirements of the CGMPs, 21 CFR 820.30 Lecture 2: The Design History File - documenting Product Design Control and its nine elements  Lecture 3: The Device Master Record and the Device History Record  Lecture 4: Summary of morning discussion  Lecture 5: Group activity on the 1) The DHF, or 2) The DMR and DHRs  Lecture 6: Review of group activity and Q&ADay 2 - AgendaLecture 7: The EU's Medical Device Directive  Lecture 8: The "Essential Requirements" and their documentation  Lecture 9: The remaining elements of a Technical File / Design Dossier  Lecture 10: ISO 14971:2012, The Product Risk Management File / Report overview  Lecture 11: DHF / TF, DD Trends  Lecture 12: Summary of morning discussion  Lecture 13: Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements  Lecture 14: Review of group activity and Q&A  Lecture 15: Summary of morning discussion  Lecture 16: Course summary discussionSpeaker Profile:John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years experience in U.S. FDA-regulated industries, 17 of which as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. Date, Venue & Price:Held 12-13 September 2013 Los Vegas, Nevada, USA.Venue: Hilton Grand Vacations Suites at the FlamingonAddress: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USAPrice: $1,295.00Register now and save $200. (Early Bird)Contact Information: Event CoordinatorToll free: 1800 447 9407Fax: 302 288 6884GlobalCompliancePanelNetZealous LLC161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA