[Class] Biotech/Med Device Software V&V

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Biotech & Medical Device Software Verification and Validation
                (IEEE Model and FDA Model)
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Class Content

Primary focus of the class is on the document trail for V&V,
Including the creation of the Verification and Validation Plan.

First, an overview of:
•  Software Engineering        •  Software Quality Assurance
•  Software Quality            •  Software Test Engineering
•  Software Quality Engineering

The class then covers:
•  Risk Management using
   -  ISO Standard 14971
•  The IEEE V&V Model using
   -  IEEE Standard 1012-1986
   -  IEEE Standard 1059-1993
•  The FDA Software Validation Model using:
   -  General Principles of Software Validation; Final Guidance
for Industry and FDA Staff dated January 11, 2002, issued by FDA
•  Other IEEE and ISO standards, and/or FDA documents, are used
as appropriate

V&V activities are addressed from an SDLC perspective:
•  Concept Phase               •  Testing Phase
•  Requirements Phase          •  Installation & Checkout Phase
•  Design Phase                •  Operation & Maintenance Phase
•  Implementation Phase

The class will address:
•  Required V&V activities     •  Optional V&V activities

Because of the breadth and depth of the subject, outside reading
and homework of the standards and regulations will be assigned.
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Target Audience

•  Systems engineers           •  Software test engineers
•  Software engineers          •  Regulatory affairs staff
•  Software quality engineers  •  Others who are involved in V&V

Prior work experience in a formal, structured systems eng'rg,
software eng'rg, Quality and/or RA environment is strongly
recommended.
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Class Details

•  Winter quarter, starting the 1st week of December
•  Tuesday nights, 7pm to 9:45 pm
•  At Santa Clara High School **
•  3000 Benton Avenue, Santa Clara
•  Room F-6 (F-wing, rear of the school)
•  Tuition = $295 ($220 for unemployed professionals)

** The class is conducted by Santa Clara Adult Education, and
held in a large high school classroom which is contracted to
SCAE
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Registration Process

•  Pre-registration (see www.scae.org for details), or
•  Attend the 1st class (bring photo I.D. and a check).
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Credentials That Other Schools Can't Match

•  SCAE (a public school) is accredited by the Western
Association of Schools and Colleges
•  SCAE is an authorized member of Mercury Interactive's
Academic Access Program
•  SCAE is listed on the State of California Eligible
Training Provider List (ETPL) as a training provider in
software quality and software testing.
•  SCAE’s High Tech Program recently received the “Program
of Excellence” award from the Dept. of Education of the
State of California.
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Leonard Schwartz, Instructor
High Technology Program
Santa Clara Adult Education (SCAE)
Member, IEEE Computer Society
Member, SSQA
www.scae.org
[EMAIL PROTECTED]

eMailed questions about the class are welcome.
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"Providing standards-based training in software quality."
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- Special thanks to the leadership of the local sections of ASQ,
to SSQA and to IEEE for forwarding this message to their
members.
- Add'l thanks to the U.S. Army Software Metrics Office for
their contribution of training materials.