Course Description

Course Name:	Software Development for Medical Device Manufacturers - An Intensive Two-day Workshop
Time & Date:	8:30 AM - 4:30 PM, Tuesday & Wednesday, April 6 - 7
Location:	Holiday Inn Select Hotel, 15 Middlesex Canal Park Road, Woburn, MA
Speaker:	Steven Rakitin, Software Quality Consulting Inc.
Textbook:	Software Verification & Validation for Practitioners and Managers, 2nd ed, 2001. Author, Steve Rakitin

Course Summary:

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 portion of the Quality System Regulation (820.30) is discussed from the perspective of software. Several tangential discussions on key topics such as Requirements, Design Reviews, Software Verification, Software Validation and Risk Management are included in the workshop. In addition, requirements for validating software development tools and software used in Manufacturing and as part of the Quality System are also discussed. Interactive group 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
- Guidance Documents:
  - Guidance for Content of Pre-market Submissions for Medical Devices Containing Software
  - Off-the-Shelf Software Use in Medical Devices
  - General Principles of Software Validation
  - Guidance for the Use of Computers in Clinical Trials
  - Guidance on Cyber Security and Network Devices
- International Standards and Technical Reports
  - ISO 13485, ISO/IEC 62304, ISO 14971, TIR-32, TIR-36
  - Update on IEC 80001-1
- Types of Medical Device Software Regulated by FDA
- Procedures, Work Instructions and Records
Interpreting Design Controls for Software
- Discussion of all Design Control Sections from software perspective
  - 820.30(a) General Requirements
  - 820.30(b) Design and Development Planning
    - Software Development Lifecycle Models
  - 820.30(c) Design Inputs
    - About Requirements…
    - Requirements Exercise
  - 820.30(d) Design Outputs
  - 820.30(e) Design Reviews
    - Design
    - Types of Design Reviews
    - Reviews as a Software Verification Tool
  - 820.30(f) Design Verification
    - Unit and Integration Testing
  - 820.30(g) Design Validation
    - Testing Principles
    - Software Validation Process
    - Software Validation Testing
    - Validation Exercise
  - 820.30(h) Design Changes
  - 820.30(i) Design Transfer
  - 820.30(j) Design History File
Validation of…
- Software Development Tools
- Software Used in Manufacturing and Production
- Software Used as Part of Quality Systems
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
Summary

Speaker 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.

Registration includes, notes, text, coffee breaks and lunches

Decision (Run/Cancel) Date for this Courses is Monday, March 29, 2010

FEES

Payment received by March 25: IEEE Members $595

Payment received by March 25: Non-members $625

Payment received after March 25: IEEE Members $625

Payment received after March 25: Non-members $650

On-line registratiion to this course is closed. You may register from 8:00AM - 8:30AM, Tuesday, April 6, 2010 at the Holiday Inn Select, 15 Middlesex Canal Park Road, Woburn, MA or by calling the IEEE Boston Section office at 781-245-5405.