 |
This
comprehensive course for medical device manufacturers presents risk
management concepts used throughout the quality system as well as
the lifecycle of the product, from design…to manufacturing…through
post-production.
Course
Objectives
The
program will cover the basic terms of risk management, the appropriate
tools for risk evaluation, FDA's expectations for submissions and
compliance, as well as how to apply risk management principles to
various aspects of a quality system. ANSI/AAMI/ISO 14971:2007 and
the GHTF guidance, Implementation of Risk Management Principles
and Activities within a Quality Management System, will also
be highlighted throughout the course.
Format
This 2½ day program provides intensive coverage of integrating
risk management practices and principles into a medical device manufacturer's
quality system. This highly interactive format includes relevant
examples from a broad product spectrum that demonstrate current
industry practices of risk management. In addition, interactive
exercises will allow participants to practice applying risk management
concepts, principles, and tools throughout the product lifecycle.
Program
At-A-Glance
DAY
ONE
8:00
AM-5:00 PM |
Risk
Management Throughout Product
Life Cycle
|
| Basic Terms and Concepts |
| ANSI/AAMI/ISO 14971:2007 Overview |
| Management Responsibilities |
DAY
TWO
8:00
AM-5:00 PM |
Design Input |
| Design
Output |
| Design
Transfer |
DAY
THREE
8:00
AM-12:00 PM |
Overall
Residual Risk |
| Software Risk Management |
| Production and Post-Production
Information |
| Risk-Related Compliance Expectations |
|
Course Materials
Participants
will receive a comprehensive notebook of all training materials.
Also distributed are the reference documents, ANSI/AAMI/ISO 14971:2007
- Medical devices - Application of risk management to medical devices, and GHTF Study Group 3's new guidance document,
Implementation of Risk Management Principles and Activities within
a Quality Management System.
Who
Should Attend?
Instruction is targeted to quality assurance and regulatory
affairs personnel, design and process engineers, manufacturing and
operations managers, members of research and development or new
product development teams. For participants to gain the maximum
benefit from this course, it is recommended for those who have a
working knowledge of the Quality System regulation and design controls
or who have already attended AAMI's Quality System and Design Control
courses.
Dates
and Hotels
| DATE |
LOCATION |
PHONE & RATES |
| May 12-14, 2008 |
The Ritz Carlton, New Orleans
921 Canal Street
New Orleans, LA 70112
Website |
800-826-8987/ 504-524-1331
$199 single/double
rate through April 11, 2008 |
| Oct 1-3 , 2008
|
The Westin Arlington Gateway *
801 North Glebe Road
Arlington, VA 22203
Website |
888-627-7076
/ 703-717-6200
$199 single/double
rate through Sep 3, 2008 |
| NOTE: Reservation requests should be made as soon as possible, but no later than the "rate through" date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. |
| * Due to the number of events that AAMI is holding at the Westin Arlington Gateway in 2008, it is necessary to specify precisely which course you are attending when making your room reservation. |
|
Faculty
This course is taught by
a mix of independent experts, industry representatives experienced
in risk management, and FDA personnel. These instructors provide
a balanced presentation of many aspects of risk management principles
and practices as described in the objectives
above.
Registration
Fees
Fee
includes all course materials, continental breakfast, and refreshment
breaks for three days; and lunch for the first two days of the course.
| REGISTRATION
TYPE |
2008
FEES |
| AAMI
Corporate & Institutional Member |
$1685 |
| AAMI
Individual Member |
$1785 |
| Nonmember |
$2085 |
| Government
Employee |
$585 |
|
Join
AAMI and Save!!
Link
to Membership
| MEMBERSHIP
TYPE |
2008
FEES |
| U.S.
Individual Membership Rate |
$200 |
| Non-U.S.
Individual Membership Rate |
$260 |
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