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Highlights from last year's conference:
“Excellent forum to
meet people from the industry and FDA in a relaxed setting.”
Russ Davies, Vice President, Regulatory Affairs and Quality Systems,
Smiths Medical, NA
“This conference was very
enlightening, especially in trends regarding quality.”
Bob Jaksih, Director of Technical Services, Perkins Electronics
“...the
FDA’s list of
recalled devices
that could pose serious health problems or death
has grown over the last five years, with 18 so far this
year...”.
—
The Boston Globe,
September 1, 2004 |
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Pre-Conference
Workshops:
Tuesday, April 5
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BACK BY
POPULAR DEMAND! -- |
Pre-Conference Workshop A
- AM Half-Day Session
CAPA - Management
and Executive Responsibility
 INSTRUCTOR:
John Malloy
[BIO]
President
John Malloy and Associates, Inc.
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Here’s what
participants at the inaugural Med Device Quality Congress said
about John Malloy and why we’ve expanded the length and depth of
his presentation…
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Great! Not enough time!
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Excellent examples from when
John was an FDA investigator
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This presentation was
fantastic. I wish he had a longer time to speak.
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Excellent talk. I believe this
could be a 1.2 day talk.
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Best presenter of the seminar!
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Excellent presentation.
Speaker was extremely knowledgeable of the topic
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Very informative and well
presented
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Understanding Software Validation
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Defining the scope
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Understanding impact to the
business
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Understanding the
Systems-Engineering perspective
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Developing and Maintaining an
Applications Portfolio
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Assessing the need for
validation
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Defining a risk-based approach
to prioritize validation efforts
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Identifying the impact of 21
CFR Part 11 on the validation efforts
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Implementing a robust validation methodology
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Using a life cycle approach
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Defining the essential set of
supporting processes and procedures
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Evaluating cost and resource
requirements
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Developing
a cost-effective approach to execution
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Performing Gap Assessments
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Using the Six-Sigma Approach
for Problem Solving
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Identifying the hidden costs
in Remediation
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Implementing corrective and
preventive measures
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Monitoring for effectiveness
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Presented by:
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