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

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