The DHF, Technical File and Design Dossier - Similarities, Differences and The Future

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. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF.

Who Will Benefit:

This workshop will provide valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files / Design Dossiers, documents, activities / plan(s). This information addresses Medical Device documentation requirements and implementation. The employees who will benefit include:

• Senior and middle management and staff
• Regulatory Affairs
• QA/QC
• R&D
• Production Management
• Manufacturing Engineers
• Process Engineers
• Project Managers
• Vendors, sales and marketing
• Any tasked with medical device development, documentation, and regulatory responsibilities

Speaker 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. 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. 

Date, Venue & Price:

Held 12-13 September 2013 Los Vegas, Nevada, USA.

Venue: Hilton Grand Vacations Suites at the Flamingon

Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA

Price: $1,295.00

Register 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

Contact Information:
Event Coordinator

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Fax: 302 288 6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

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