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2day Inperson Seminar on The DHF Technical File and Design Dossier Similarities and Differences

9/12/2013 9:00 AM - 9/13/2013 6:00 PM

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


• R&D

• Production Management

• Manufacturing Engineers

• Process Engineers

• Project Managers

• Vendors, sales and marketing

• Any tasked with medical device development, documentation, and regulatory responsibilities

Course Outline:

Day 1 - Agenda

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 - Agenda

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

Speaker Profile:

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.

Date, Venue & Price:

Held 12-13 September 2013 Los Vegas, Nevada, USA.

Venue: Hilton Grand Vacations Suites at the Flamingon

Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA

Please note the registration will be closed two days (48 hours) prior to the start date of the seminar.

Price: $1,295.00

Register now and save $200. (Early Bird)

Until July 31, Early Bird Price: $1,295.00

from August 01 to September 10, Regular Price: $1,495.00

Call our representative on 1800 447 9407 to have your seats confirmed.

Limited seating, bookings essential!

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884





NetZealous LLC

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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