The DHF, Technical File and Design Dossier - Similarities, Differences and The Future 2014

This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

We will consider the following:

• The Design Control requirements of the CGMPs, 21 CFR 820.30

• The Design History File - documenting Product Design Control and its nine elements

• The Device Master Record and the Device History Record

• The EU’s Medical Device Directive

• The "Essential Requirements"; and their documentation

• The remaining elements of a Technical File / Design Dossier

• Trends

• Two attendee projects

Why should you attend?

This seminar / workshop 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, their similarities, 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; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or Notified-Body reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the U.S. FDA and the EU Notified Body will be discussed.

Course Outline:

Day 1 – Agenda

Lecture 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<