|
Class: "Biotech & Medical Device Software
V&V"
A Foundation-Level Verification and Validation Class
- Building systems or software that are mission-critical,
life-critical or life-support oriented? Then verification
and validation (V&V) is likely a requirement that has been
imposed on the overall development cycle.
- Does your company have staff that need to understand V&V
activities step-by-step, or SDLC phase by SDLC phase?
Audience
The target audience is:
- Systems engineers
- Software engineers
- Software quality engineers and other software quality staff
- Software test engineers and other software testing staff
- Regulatory affairs staff
- Other individuals who manage or perform work in support of
regulatory compliance
Prior work experience in a formal, structured software
engineering, quality and/or RA environment is recommended.
Class Content
Primary focus of the class is the creation of the Software
Verification and Validation Plan (SVVP) by developing an
understanding of V&V tasks.
First, there is an initial overview of:
- Software Engineering
- Software Quality
- Software Quality Engineering
- Software Quality Assurance
- Software Test Engineering
The class will then follow:
- "General Principles of Software Validation; Final Guidance
for Industry and FDA Staff" dated January 11, 2002, issued by
FDA's Center for Devices and Radiological Health
- IEEE Standard 1012-1986
- IEEE Standard 1059-1993
- Other IEEE standards
V&V activities will be discussed from the product life cycle
perspective, to wit:
- Management of V&V
- Concept Phase V&V
- Requirements Phase V&V
- Design Phase V&V
- Implemenation Phase V&V
- Testing Phase V&V
- Installation and Checkout Phase V&V
- Operation and Maintenance Phase V&V
The class will consider:
- Required V&V activities
- Optional V&V activities
Because of the breadth and depth of the subject, outside
reading and homework related to standards will be assigned.
(This isn't your typical adult education class.)
Class Details
- Class ticket no. 621427 (write this number down)
- Winter quarter, starting December 3, 2002
- 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; park in the back)
- Tuition = $150
** The class is conducted by Santa Clara Adult Education,
but is conducted in a large high school classroom
Registration
Because this class offering was announced late, we are
accepting enrollments through December 13. (We will help
late enrollees to "catch up.")
To facilitate enrollment, students may:
- Pre-register (see www.scae.org for details), or
- Just come to the class (bring photo I.D. and a check).
High Technology Program
Santa Clara Adult Education
www.scae.org
"Providing standards-based training in software quality
and software testing."
For more information call 408-423-3523
or Lyuba Iserlis 408-295-4111
Website: www.scae.org
Classes
descriptions... 
|
