Seminar · Las Vegas, Nevada
The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
Health · Medicine · Pharmaceuticals
Key numbers
- Editions on record
- 2first in 2014
About The DHF, Technical File and Design Dossier - Similarities, Differences and The Future
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
Learning Objectives:
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.
Day 1 Schedule with John E Lincoln
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
Lecture 6: Review of group activity and Q&A
Day 2 Schedule with John E Lincoln
Lecture 7: The EU's Medical Device Directive
Lecture 8: The "Essential Requirements" and their documentation
Lecture 9: The remaining elements of a Technical File / Design Dossier
Lecture 10: ISO 14971:2012, The Product Risk Management File / Report overview
Lecture 11: DHF / TF, DD Trends
Lecture 12: Summary of morning discussion
Lecture 13: Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements
Lecture 14: Review of group activity and Q&A
Lecture 15: Summary of morning discussion
Lecture 16: Course summary discussion
Meet your Expert:
John E Lincoln, is Principal of
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2014 | 9–10 Oct 2014 | Hilton Grand Vacations Suites at the Flamingo Las Vegas, Nevada | — | — |
| 2014 | 28–29 Aug 2014 | Hilton Grand Vacations Suites at the Flamingo Las Vegas, Nevada | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is The DHF, Technical File and Design Dossier - Similarities, Differences and The Future?
The next dates haven't been confirmed. The last edition we have on record was 9–10 Oct 2014.
Where is it held?
The last edition we have was at Hilton Grand Vacations Suites at the Flamingo, Las Vegas, Nevada.