Seminar on the DHF, Technical File and Design Dossier
$1,295
Seminar on the DHF, Technical File and Design Dossier

Seminar on the DHF, Technical File and Design Dossier

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Embassy Suites Convention Center Las Vegas

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

Las Vegas, NV, NV 89169

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Event description

Description

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

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

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

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Date and Time

Location

Embassy Suites Convention Center Las Vegas

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

Las Vegas, NV, NV 89169

View Map

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