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Design
Control for Medical Devices
Meeting FDA’s 21 CFR 820.30 Rules
for Quality Design and Manufacturing
2 day course (8:30 a.m. - 5:30 p.m.)
Get Your Training Direct from Former
FDA Device Officials
Learn straight from the source
– former FDA inspectors, rulemakers, and trainers
from the global consulting team of
EduQuest.
- March 18-19, 2010, Las Vegas, NV
- September 21-22, 2010, Wilmington, DE
Design
control is required for all medical devices sold in the U.S., EU, Japan,
and several
Other countries. In addition, there’s relentless
pressure from both FDA and Congress to
improve device design control and
manufacturing.
By registering for this two-day Design Control course, you
will:
- Learn
how FDA expects you to develop, implement, and manage design control
- Focus
on overcoming one of the biggest obstacles that confounds device
companies – accurate and consistent transfer of product design to
actual
manufacturing operations
- Discover
how FDA’s design control rules relate to product standards
established in ISO 9001:2000 and ISO 13485
Your EduQuest instructors are former FDA
investigators, including the founding editor
and co-author of the FDA’s “bible” for
inspectors, the Investigations Operation Manual (IOM),
as well as experts from the regulated community.
Can’t make these dates?
Subscribe to free EduQuest-ions & Answers Compliance
Newsletter
to learn
when new dates and locations are scheduled.
Course
Content:
·
Why does FDA
Require Design Controls?
o
FDA’s major areas
of concern
o
CRDH’s
cradle-to-grave vision: The Total Product Life Cycle
o
Design control
as part of the Quality System Regulation (QSR)
o
FDA’s
definition of key design terminology
·
FDA Guidance
for Design Control
o
Defining a
“substantially equivalent” production unit
o
Understanding
difference between a deviation vs. nonconformance
o
Understanding
difference between project design vs. product design
o
How
international standards relate to FDA’s expectations
·
Design and
Development Planning – 21 CFR 820.30 (b)
o
Implementing
top-level design control procedures
o
Elements of
the General Development Plan (GDP)
o
Best practices
in design planning
·
Design Review
– 21 CFR 820.30 (e)
o
Types of
review
o
Proven design
review methods
·
Design Input –
21 CFR 820.30 (c)
o
Understanding
inputs vs. outputs
o
Typical input
documents
o
Using FDA
recognized standards and guidance
o
Importance of
Human Factor considerations
o
Good and bad
examples of requirements
·
Design Output
– 21 CFR 820.30 (d)
o
Process
control outputs
o
Other final output
documents
o
Conducting
design output review
·
Design
Verification – 21 CFR 820.30 (f)
o
Verification
documents
o
Understanding
difference between verification vs. validation
o
Elements of a
test protocol
o
What FDA looks
for in test reports
o
What if the design
fails V&V?
·
Design
Validation – 21 CFR 820.30 (g)
o
How FDA
defines validation
o
Key validation
documents and methods
o
Conducting
design validation review
·
Design Change
– 21 CFR 820.30 (i)
o
Developing a
change control policy
o
Role of
planned, temporary changes
o
Identifying
all areas impacted by change
o
Conducting
re-verification and re-validation
·
Design
Transfer to Manufacturing – 21 CFR 820.30 (h)
o
Integrating
manufacturing considerations into design
o
Key design
transfer documents
o
Developing a manufacturing/transfer
plan
o
Proven design
transfer methods
·
Lessons
learned in Design Transfer
o
Documentation
reminders
o
Impacts on
tooling and components
o
Conducting
design transfer review
o
Importance of
process control review
·
Design History
File (DHF’s) – 21 CFR 820.30 (j)
o
FDA
requirements for design history
o
Responsibilities
of team leaders
o
Relationship
between the DHF and the Device Master Record (DMR)
o
Creating a
traceable DHF index
o
Practical
suggestions maintaining compliance
To Register or Get More Details:
Email Cece Bland, Director of Training
and Information Services,
at Info@EduQuest.net or call +1 (301) 874-6031. Tuition is $1980.
Three-Day Device
Compliance Learning Package:
Save by
Attending Back-to-Back Courses
Immediately before this Design Control
course, EduQuest will offer at each location a
one-day course on QSR Fundamentals: Complying
with FDA’s Medical Device 21
CFR 820 Quality
Systems Regulation.
Save $175 when you attend both
courses. The combined tuition is
just $2795, including
three full days of hands-on-training,
all course materials, lunch, refreshments, and the
opportunity to learn and interact with
some of the top FDA compliance experts in the nation.
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