Design Control and Product Validation
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Who Should Attend
This course is intended for personnel who are responsible for
medical device design and development such as
• Engineers
• Scientists
• Project Leaders
• Technical Managers
• Senior Technicians
• Department Heads
Quality Assurance, Compliance and Regulatory personnel will
also benefit because of their responsibility for implementation,
validation and evaluation of design controls as part of the
overall quality system. Sales and Marketing personnel will
learn their vital roles in providing input to the design process
and requirements for design changes.
Description
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.
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.
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.