Supplier Qualification, Performance and Risk-based Decision Tools

Global outsourcing of materials and processes requires evaluation and control.  Performance monitoring of important attributes by using Risk Based decisions is a key to sleeping well at night.

Jim Shore, Principal Quality Engineer, Corporate Alliance Quality Department Boston Scientific

Jim Shore is a Principal Quality Engineer in the Corporate Alliance Quality Department of Boston Scientific in Natick, Massachusetts.  He currently is working on the development and implementation of the formal Risk-based Product focused Assessment Program (REPACE) that reduced OEM-related Field Actions by 90%. Since 1989, Jim has worked in Quality and Supplier Management in various industries; capital equipment semiconductor, aerospace, defense contractors, and medical devices. Prior to joining Boston Scientific, Jim was Quality Manager at Aspect Medical, Corporate Supplier Quality Engineer at ACMI (now Gyrus ACMI), and Business Process Improvement Manager at Brooks Automation and Material Quality Engineer at Raytheon. 

Peter Ashe has over 21 years of high tech experience working in quality assurance, reliability engineering and manufacturing.  During his career, Mr. Ashe has directly managed all aspects of quality and reliability engineering including supplier quality engineering, factory and quality systems assurance, reliability and test engineering, environmental health and safety, and software quality engineering.  Most recently, Mr. Ashe served as Vice President of Quality and Reliability Assurance for Brooks Automation, who provides automation, vacuum and instrumentation solutions primarily to the semiconductor manufacturing industry worldwide.  Mr. Ashe has successfully led quality management system improvement initiatives - both at the corporate and division level – in areas of supplier management, factory quality, and customer satisfaction.  His accomplishments in each of these areas have contributed to Brooks’ success as the premier semiconductor automation equipment supplier. Mr. Ashe holds a Bachelor of Science in Electrical Engineering from Boston University, and an MBA from Boston College.  He is a member of the American Society for Quality (ASQ).

Software Qualification and Data Analysis of Statistical  Applications: A Risk Based Approach Designing a New Process

This presentation will describe the qualification approach to statistical applications utilizing GAMP 5 methodology.

Judith S. Samardelis, Sr. Manager QA Validation Wyeth Biotech

Judy Samardelis has been in the industry more than 17 years in various roles of Quality Control, Study Director of Preclinical Studies, Drug Delivery, Assay Development and Validation and several years specializing in Computer and Laboratory Validation using GAMP® methodology in support of several Wyeth Biotech sites. In her current role, she has successfully implemented a Qualification Program for Statistical Applications using a risk-based approach as well development of a PQ by Exception methodology to streamline validation activities. She is Co-Chair of the GAMP® Risk SIG team and Co-Chair of the Pharmaceutical Engineering Committee Editorial Review Board. GAMP® COP, PAT COP, C&Q COP, as well as a reviewer of the GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems guide and The Commissioning and Qualification Baseline ® Guide. Samardelis has a B.A. in Microbiology from the University of New Hampshire, Durham.

Software Change Management For Medical Devices

Change during the software lifecycle is inevitable. Even with great quality planning changes surface in the requirements, design, testing and post release activities.  Lack of change management in a software project can be frustrating, inefficient to unprofitable and in medical devices; harmful to users or patients.

An appropriate software change management process drives communications, decision making, predictability, compliance, product quality and above all; ensures safety and efficacy.

Tony Raymond, President, New Harbor SQA

Tony Raymond, President and Sr. Consultant; is the founder of New Harbor SQA, LLC that provides consulting and management to help companies dramatically improve the productivity and performance of their software testing, quality assurance and development processes.

Tony has led efforts in software and hardware testing, program management, quality assurance, complex system integration, customer satisfaction, supplier management and software development. He holds a BSEE from Worcester Polytechnic Institute and has done post graduate study in business management and executive leadership at WPI, Northeastern University and Babson College.  He is an ASQ Certified Manager of Quality and Organizational Excellence. In 2008 Mr. Raymond received The Boston Society Award from the Boston Section for Demonstrated Meritorious And Most Distinguished Achievement On Promoting The Quality Principles And In Exemplifying The Ideals Of The Quality Profession.

Performance Excellence: Effective Quality Systems Achieved Through Integrated Methodologies

Integrating  various quality system approaches and tools to enable its organization to achieve the goals of its vision, mission, and strategic plan.  The Baldrige performance excellence criteria is utilized as the management system model and for structured organizational assessments and diagnostics, resulting in the identification and prioritization of improvement opportunities.  Lean and six sigma concepts are used as the improvement engine, with ISO 9000/MPTQM serving as the standardization tool.  As a driver Lean and Six Sigma are powerful, complimentary tools for process improvement.  To make dramatic improvement in cost, quality, and responsiveness, organizations must eliminate critical-to-quality issues and delays due to time traps using both Lean and Six Sigma concepts.  Combining Six Sigma tools to reduce variation and eliminate process induced defects, with Lean tools to increase process speed is a great combination for process improvement.    Steve will describe how DST Output has deployed these approaches in a manner linked to its strategic objectives.  He will describe how to determine which approach to take, the benefits of each, and will provide some examples of projects that have led to significant results.

Steven Hodlin, Vice President, Business Excellence, DST Output

Impact of ISO 9001:2008 in a 2009 Economy

ISO 9001:2008 bears a striking resemblance to the 2000 edition, so getting through the reassessment audit is no big deal, right?  This presentation will address this central question, and provide "New England-thrifty" solutions for consideration.

Glen Emelock, Senior Partner, The CRO Group, Inc.

Glen Emelock brings over 30 years of experience in medical device, in vitro diagnostic and biotechnology product development, quality and regulatory affairs.  He is the Senior Partner with The CRO Group, Inc., a consulting firm, specializing in domestic and international regulatory affairs, product approvals, quality systems, performing notified body/CMDCAS audits, and market access.  His past employment includes Hardware and Software Development Manager for Millipore Corporation from 1984 to 1993, where he led the development of computer/microprocessor based, software driven pharmaceutical, medical and laboratory instrumentation systems and provided international and software regulatory expertise for several Millipore divisions, and Director of Notified Body North American Operations for TÜV Product Service, responsible for establishing and implementing ISO 9001, ISO 13485, and EU Directive/CE Marking certifications for over 200 medical device and in vitro diagnostic manufacturers from 1993 to 1996.