The DHF,Technical File & Design Dossier-Similarities,Diff & The Future

Details:

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


Image result for The DHF,Technical File & Design Dossier-Similarities,Diff & The Future

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


Address: Embassy Suites Convention Center Las Vegas, 3600 Paradise Road, Las Vegas, NV 89169

Start Date: 2017-03-02

Last Date: 2017-03-02

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