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

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.

Who Will Benefit:

This workshop will provide valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files / Design Dossiers, documents, activities / plan(s). This information addresses Medical Device documentation requirements and implementation. The employees who will benefit include:

• Senior and middle management and staff
• Regulatory Affairs
• QA/QC
• R&D
• Production Management
• Manufacturing Engineers
• Process Engineers
• Project Managers
• Vendors, sales and marketing
• Any tasked with medical device development, documentation, and regulatory responsibilities

Agenda:

Day 1 Schedule

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:

Lecture 1:

The EU's Medical Device Directive

Lecture 2:

The "Essential Requirements" and their documentation

Lecture 3:

The remaining elements of a Technical File / Design Dossier

Lecture 4:

ISO 14971:2012, The Product Risk Management File / Report overview

Lecture 5:

DHF / TF, DD Trends

Lecture 6:

Summary of morning discussion

Lecture 7:

Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements

Lecture 8:

Review of group activity and Q&A

Lecture 9:

Summary of morning discussion

Lecture 10:

Course summary discussion

Price: $1,295.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until November 10, Early Bird Price: $1,295.00 from November 11 to January 12, Regular Price: $1,495.00

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Registration Link - http://bit.ly/The-DHF-Technical-File-and-Design-Dossier