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Glenn
McCarty Speaks on Risk at the
CBI Conference for Risk Management |
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FARMINGDALE,
NY (08-01-07): Glenn
McCarty, CEO of EtQ, recently
spoke at the Center for
Business Intelligence (CBI)
Medical Device Risk Management
Summit, held at the Doubletree
Hotel in Washington, D.C.
on July 16-17.
The medical device &
diagnostic industry uses
several different models
to assess risk. When assigning
a risk index to a medical
device, the first challenge
is to decide the appropriate
technique to use. A proper
risk assessment is critical
to providing the safest
and highest quality products.
Using the appropriate
risk model for your device
assists you in meeting
your safety and quality
goals. The CBI Medical
Device Risk Management
Summit was held to receive
an in-depth analysis of
three different models
of risk assessment; the
Failure Mode Effects Analysis,
(FMEA, bottom up method),
the Fault Tree Analysis
(FTA, top down method)
and Hazard Analysis of
Critical Control Points
(HACCP).
Glenn's presentation,
"Techniques for
applying Risk-based methods
to streamline the CAPA
process" provided
insights into the growing
need to incorporate risk
methodologies in order
to reduce the number of
CAPAs within a system.
The session focused on
why CAPAs need risk assessment,
how to apply risk, and
real-world examples of
how using this technique
can benefit a quality
system. "Using risk
assessment, companies
in all industries are
able to filter out the
critical events versus
non-critical events and
dedicate more energy and
resources to the events
that have the most impact
on the business."
The conference was a
huge success in identifying
leading concepts in the
medical device industry
regarding risk assessment
and risk management. EtQ
continues to participate
in these conferences and
summits in an effort to
help industry professionals
seek new methods for automating
and simplifying their
quality and compliance
processes.
About
EtQ
EtQ is the leading Enterprise
Quality and Compliance Management
Software for identifying,
mitigating and preventing
high-risk events through
integration, automation
and collaboration. EtQ uses
best in class, integrated
modules and enterprise application
integration to manage and
measure quality and compliance
processes and execute organizational
change. Key modules within
the product include: Document
Control, CAPA (Corrective
and Preventive Action),
Audits, Complaint Handling,
Risk Management, Change
Management, Employee Training,
Nonconforming Materials,
Enterprise Reporting and
more than 20 additional
compliance-oriented modules.
With its world class flexible
workflow, collaborative
platform EtQ has developed
a unique niche to support
enterprises involved in
various compliance management
initiatives such as; cGxP
(FDA), ISO 13485, ISO 9000:2000,
ISO/TS 16949, ISO 14001,
AS 9001, TL 9000, OHSAS
18001, RoHS and similar
standards for compliance
and regulatory management.
EtQ has been providing compliance
solutions to a variety of
markets for over fifteen
years.
For more information or
to schedule a virtual demo,
contact EtQ Inc., at 800-354-4476
or 516-293-0949, or e-mail
us at
.
Contact: Tim Lozier
EtQ, Inc.
800.354.4476 ext. 19
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EtQ
is a trademark of EtQ
Management Consultants,
Inc. All other product
names and company names
are trademarks or registered
trademarks of their respective
owners.
This release is intended
for informational purposes
only.
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