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Seminar on the DHF, Technical File and Design Dossier - Similarities, Differences and the Future

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Overview

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.

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

Speaker:

John E Lincoln

Consultant, Medical device and Regulatory affairs, 

John E Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, 17 of which as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment V&V including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on V &V, CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, root cause analysis, and others. John is a graduate of UCLA.

 

Location: Las Vegas, NV Date: March 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: Embassy Suites Convention Center Las Vegas, 3600 Paradise Road, Las Vegas, Nevada, 89169, USA

Use CNY2017 Promo Code to Get Flat 50% OFF on ALL SEMINARS

Expire Date : 01-January-2017

Price:

$1,295.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com 

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