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Faculty: John E. Lincoln

  • Date: 9/15/2020 01:00 PM - 9/15/2020 02:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event


This important webinar will talk about the FDA's DHF, DMR, DHR, the EU's MDD TF/DD and new MDR TD - Documentation to meet their different purposes, future directions, and the effects of the one year delay in implementation due to COVID-19. 

We will examine the existing and proposed requiements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements currently being phased out and the new MDR Technical Documentation being phased in. The effects of the one year delay in implementation will be evaluated. It will 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; Similiarities and differences; Future trends;  Typical DHF / D&DPF Table of Contents; Technical File / Documentation Table of Contents; The importance and usefulness of the old "Essential Requirements" and new "General Safety and Performance Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why You Should Attend:

One of our most popular webinars, continuously updated with the latest U.S. FDA and European  Union requirements. How does the one year delay in implementation of the EU MDR due to COVID-19 impact stakeholders. 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 FiIe or Design Dossier under the old EU MDD, and the Technical Documentation requirements of the new EU MDR.  Currently they serve differnt purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both. And how to address the sudden change in full implementation date.

Areas Covered in the Session :

  • The One year Implementation Delay
  • The U.S. FDA's DHF and EU's D&DF
  • The EU's MDD and the Technical File / Design Dossier; The EU's new MDR's Technical Documentation
  • MDD's "Essential Requirements" and MDR's "General Safety and Performance Requirements" 
  • Device Classification -- U.S. FDA vs. EU MDD
  • Design Contol vs. a Product 'Snapshot in Time'
  • DHF / D&DPF "Typical" Contents
  • The DMR and DHR / Lot / Batch Record
  • TF / DD / TD Expected Contents
  • Parallel Approaches to Documentation -- Teams
  • FDA and NB Audit Focus

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Consultants
  • Senior management in Drugs, Devices, Combination Products