Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future at Las Vegas, NV | January 14, 2016 9:00 AM - January 15, 2016 6:00 PM | Automation.com

Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future at Las Vegas, NV

Event Summary

DATE:
January 14, 2016 - January 15, 2016
LOCATION:
Las Vegas, NV 89169
COUNTRY:
United States
START DATE/TIME:
January 14, 2016 9:00 AM
END DATE/TIME:
January 15, 2016 6:00 PM
EVENT TYPE:
Training
HOST:
Globalcompliancepanel
PHONE:
18004479407
EMAIL:
[email protected]
WEBSITE:
Click here to Visit

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

Date: January 14th & 15th, 2016 and Time: 9:00 AM to 6:00 PM

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

For More Update Click Here: https://www.linkedin.com/company/globalcompliancepanel

Quick Contact:

NetZealous BDA as GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 1-800-447-9407
Fax: 302-288-6884
[email protected]
http://www.globalcompliancepanel.com

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

MORE EVENTS

  • Avnet IoT Workshop on How to start your next IoT project

    Getting the right start when you’re implementing IoT in your business is critical. Our IoT readiness workshop is designed by industry experts who...

  • Green Datacenter Conference

    Green Datacenter Conference will feature all new talks, and interactive sessions designed to help you implement secure, efficient data center...

  • PLM Certificate Program

    For 35 years, CIMdata has been working in the Product Lifecycle Management (PLM) industry. Our consulting services and research expertise are known...

  • Tire Technology Expo 2019

    Tire Technology Expo is Europe's most important tire manufacturing technology exhibition and conference. Exhibits cover the complete spectrum of...

  • Industry of Things World USA

    The Industry of Things World team invites you to connect with over 500 Industrial Internet experts on Mar 07-08, 2019 at the Marriott Marquis San...

VIEW ALL

RELATED