The DHF, Technical File and Design Dossier - Similarities, Differences and The Future 2014
conferences > Health conferences > The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
August 28 - 29, 2014
Las Vegas NV , USA
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<
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<
Venue
Location: Hilton Grand Vacations Suites at the Flamingo
Ideally positioned in the extensive 15-acre Flamingo property at the most famous corner of the Las Vegas Strip with Bally's, Caesars and the Bellagio, this convenient Las Vegas hotel is a resort..
+1-702-697-2900
