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.

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
The DHF, Technical File and Design Dossier -
Similarities, Differences and The Future
Las Vegas, NV
March 2nd & 3rd, 2017
9:00 AM to 6:00 PM
John E Lincoln
Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
John E Lincoln is Principal of J. E. Lincoln and
Associates LLC, a consulting company. John, a graduate of UCLA,
is a medical device and Regulatory Affairs consultant. He has
helped companies to implement or modify their GMP systems and
procedures, product risk management and U.S. FDA responses. In
addition, he has successfully designed, written and run all types of
process, equipment and software qualifications/validations, which
have passed FDA audit or submission scrutiny, and have been
described in peer-reviewed technical articles and workshops
worldwide.
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
$6,475.00
Price: $3,885.00 You Save: $2,590.0 (40%)*
Register for 5 attendees
Consultant, Medical device and Regulatory affairs

2. Global
CompliancePanel
Agenda:
Day One Day Two
Lecture 1: The Design Control requirements of the CGMPs,
21 CFR 820.30
2-day In-person Seminar:
The DHF, Technical File and Design Dossier -
Similarities, Differences and The Future
Why you should attend Who Will Benefit:
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
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.
Lecture 5: Group activity on the 1) The DHF, or 2) The DMR
and DHRs
 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
Lecture 6: Review of group activity and Q&A
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
Lecture10: Course summary discussion

3. Global
CompliancePanel
www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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2-day In-person Seminar:
The DHF, Technical File and Design Dossier -
Similarities, Differences and The Future