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About our Program: |
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Computer software and hardware system
validation is required for Good Laboratory Practices compliance by
both US and international regulatory agencies. Industry best
practices recommend a risk-based approach to system life cycle
development and for implementing custom, configurable, commercial
off-the-shelf software systems or hosted applications. Each
development process step including analysis, user/system
requirements gathering, design, development, testing,
implementation, change control and system retirement is critical for
a compliant quality system. Documentation at each stage insures
adequate validation for regulatory inspections. Combining FDA
regulations with their initiative for a risk-based approach to
computer system compliance addresses user and regulatory
requirements. |
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About our Presenter: |
James Joy earned his BS in computer science from
Rochester Institute of Technology and an MS in Information
Technology from the University of Rochester’s Simon School. His
nearly 20 years of work experience comes from a broad range of
FDA regulated environments such as pharmaceutical
R&D/Manufacturing, medical device and biotechnology. As a
software engineer with Fisons/Medeva, he wrote and validated
software on clinical systems and for the manufacturing lines.
Moving into the R&D arena, he worked on implementing Beckman’s
first windows based LIMS system. As a senior software validation
expert at Bausch & Lomb, he was responsible for leading the
validation efforts of global regulated software systems dealing
with medical devices.
At Wyeth Vaccines, his previous experience
allowed him to fill the role of IT R&D Department Manager. Here
he was responsible for moving vaccine testing labs forward by
implementing validated software systems to enhance speed and
efficiency. This pivotal role liaised between corporate IT and
the R&D labs creating opportunities to hone his communication
skills.
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