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

Overview

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

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Instructor 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

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Course Times

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

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

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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.

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