An Intensive Two-day Workshop

Developing software in compliance with FDA QSR regulations and international standards is no easy task. This 2-day intensive workshop provides your organization with practical guidance and suggestions for developing software that complies with applicable FDA regulations and guidance documents and international standards. The focus of this workshop is interpreting Design Controls for Software. Each section of the Design Controls regulation (820.30) is discussed from the perspective of software. Several tangential discussions on key topics such as Requirements, Design Reviews, Software Verification & Validation and Risk Management, are included in the workshop. In addition, requirements for validating software development tools and software used in Manufacturing are also discussed. Interactive exercises are included to facilitate discussion and learning.

WHO SHOULD ATTEND: Software engineers, project managers, quality managers, software quality professionals, and anyone who needs to develop cost-effective processes and procedures that will enable their organizations to deliver high quality devices that comply with the international standards and FDA regulations.

WORKSHOP OUTLINE

• Introduction

  FDA Regulations: QSR and 21 CFR Part 11

  FDA Guidance Documents

  International Standards and Technical Reports

  Types of Medical Device Software

  Procedures, Work Instructions and Records

   

• Interpreting Design Controls for Software

  Software Development Models

  Design and Development Planning

  Design Inputs

    About Requirements…

    Requirements Exercise

  Design Outputs

  Design Reviews

  Design Verification

    Software Verification Process

    Testing Overview

  Design Validation

    Software Validation Process

    Validation Exercise

  Design Changes

  Design Transfer

  Design History File

   

• Risk Management

  Standards and Regulations

  Terms and Concepts

  Risk Management Process

  Risk Management Tools and Techniques

  Fault Tree Exercise

  Data Collection and Analysis

  Documentation Requirements

   

• Validation of…

  Software Tools Used to develop Device Software

  Software Used in Manufacturing and Quality Systems

   

• Summary

Lecturer Bio: Steven R. Rakitin has over 30 years experience as a software engineer and software quality manager. He was one of the authors of the IEEE Standard for Software Quality Assurance Plans (IEEE-STD-730) and is currently on the IEEE Standard 1012 (Software Verification & Validation) Working Group. He has written several papers on the subject of software quality and published a book titled: Software Verification & Validation for Practitioners and Managers. He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He has earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a member of the IEEE Computer Society, ASQ Software Division, ASQ Biomedical Division, and Association for the Advancement of Medical Instrumentation (AAMI). He is on the Editorial Review Board for the ASQ Journal Software Quality Professional. He has presented invited papers and tutorials for the Health Industry Manufacturers Association, AAMI, ASQ, and IEEE. As President of Software Quality Consulting Inc. (www.swqual.com), he helps medical device companies comply with regulations in a more efficient and cost-effective manner. He can be reached at steve@swqual.com.

Decision (Run/Cancel) Date for  this Courses is Tuesday, April 1, 2008

Course Fee Schedule:

On-line Registration and Payment

On-line registration is closed for this course, but registration is still available on-site between 8:15AM – 8:30AM, Wednesday, April 9, 2008 at the Holiday Inn Select, 15 Middlesex Canal Park, Woburn or by contacting the office at 781-245-5405.

Copyright © 2008 IEEE Boston Section. All rights reserved.
Maintained by R M Stelting

Updated Monday April 07, 2008