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The DHF, DMR, DHR, and the Technical File-Design Dossier - USFDA and EU MDD Requirements


Wednesday, November 14, 2012
Online Training
Wilmington, United States

http://bit.ly/TuhopO

Event Type: Conference

Overview: This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents


Why should you attend:
 One of our most popular webinars, 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 cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF.
Areas Covered in the Session:

  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">The U.S. FDA's DHF
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">The EU's MDD and the Technical File / Design Dossier
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Device Classification -- U.S. FDA vs. EU MDD
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Design Control vs. a Product 'Snapshot in Time'
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">DHF "Typical" Contents
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">The DMR and DHR / Lot / Batch Record
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">TF / DD Expected Contents
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Parallel Approaches to Documentation -- Teams
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">FDA and NB Audit Focus

Who Will Benefit:

  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Senior Management in Drugs, Devices, Biologics, Dietary Supplements 
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">QA
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">RA
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">R&D
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Engineering
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Production
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Operations
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Marketing

 

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