Description
<strong>Course Schedule - 23-24 February 2009</strong><br/><br/>The course describes how to establish and implement a
system for design controls for various classes of medical
devices for both the U.S and Europe. It also provides
guidance to assist manufacturers in knowing when controls
are required. The underlying concepts will be explained in
practical terms and exercises will be used to promote
understanding. Sample procedures and forms will be provided
in both hard copy and computer disc format.<br><br>
Emphasis will be on understanding the requirements and
providing tools to assist in management of the design control
process. The course will discuss each phase of the design
process and explain the terms: design input, design output,
design review, verification, validation, and design history file.
Particular emphasis will be given to understanding the
difference between design verification vs. design validation,
and describing activities relative to validating a product
design. Also discussed will be FDA's inspection strategy and
how to manage a successful audit for design controls.<br><br>
You will return to the workplace with new tools to apply an
effective project management approach to your design
control process which will ultimately reduce time to get to
market, reduce development cost, and ensure regulatory
compliance.
11/17/2008
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Medical Device
Course Category
Brochure Name
http://www.cfpa.com/PDF/2009/1900,C8-190,0902-403.pdf
Address
Dublin, Ireland Europe