Friday, June 2, 2017 from 8:00 AM to 5:00 PM PDT
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International Technological University (ITU) 
2711 North First Street
San Jose, CA 95134





Azadeh Adibi
Course Coordinator 
ASQ Silicon Valley - Section 0613 



Suzanne Geiss

Susie Geiss
Education  Chair
ASQ Silicon Valley - Section 0613 




B120 - Software Risk Assessment, V&V for Regulated Industries 

 This course covers materials that are essential to those individuals who are interested in learning Software Risk Assessment, Verification and Validation for Regulated Industries. Course will cover variety of software types like medical device software, mobile medical apps, and quality system software’s like ERP, production systems, complaint systems, software with electronic record and electronic signatures etc., risk assessment and verification and validation based on standards like IEC 62304, ISO 14971, IEC12207, IEC 15288 and GAMP etc. Students will also learn as to how to avoid ISO audit and FDA inspection observations.
  • Introduction to Software Definitions, Types, Categories and Regulations
  • Review Software Life Cycle Process
  • Software Risk Assessment and Management Process – Hands on Workshop
  • Software Development Models
  • Software Development, Verification and Validation Process
  • Software Problem Resolution Process
  • Software Configuration Management Process
  • Software Maintenance Process
  • Learn how to write Software Life Cycle Procedure
  • How to Avoid ISO Audit and FDA Inspection Observations

Instructor Bill Kurani

Bill Kurani  

Instructor Bio

  • Mr. Bill Kurani has years of experience in product design, development, clinical trials, verification, validation, process validation & launch. Implemented Software Life Cycle based on IEC 62304, 60601, 61010, and GAMP and provided validation services


Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.


Course Details

Prerequisites: None
Hardware: N/A   |  Software: N/A                              
Required Materials: 

- Proof of online Payment 

- Pencil & Paper or laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, case studies, hands on approach, class discussions and examples
Class Time: 8 hours
Class Size:  25 max. participants
Facilities: Room with PC projector, whiteboard, etc.