Research Director - Human Factors Engineering, UL
Bio: Allison Y. Strochlic is the Research Director of UL’s human factors engineering practice, and was one of the co-founders of Wiklund Research & Design, which UL acquired in late 2012. A board-certified human factors professional with over 10 years of experience, Allison contributes to and manages research projects such as usability testing, contextual inquiry, and interviews. Furthermore, she helps clients develop key HFE documents for their design history files, including use-related risk analyses, and advises clients on how apply HFE during device development to meet regulators' expectations. Allison is co-author of Usability Testing of Medical Devices and several technical papers focused on applying HFE to medical device development. She holds a B.S. in Human Factors from Tufts University and an M.S. in Human Factors in Information Design from Bentley University.
Sr Consultant/ Medical Device Industry Community Lead, Clarkston Consulting
Bio: Allyson Hein is a Senior Consultant with Clarkston Consulting. With the firm since 2013, and with over 25 years of Medical Device industry experience, she lends her expertise in the areas of Quality Systems operations and technologies, FDA and Health Authority regulation compliance, ISO standards, continuous improvement, and change management throughout the Life Science and Consumer Product industries.
She has served in leadership positions with leading medical device companies in a wide spectrum of corporate, divisional and operational positions supporting Quality Systems compliance at all organization levels and across global interfaces. She has also held key Quality, Operational and Program Management roles with global pharmaceutical, biotechnology, food and cosmetic companies.
Allyson is passionate about ensuring compliant Quality Systems that support business objectives in an efficient manner, and helping clients deploy processes that support organizational change. Allyson received her MBA from Golden Gate University where she graduated cum laude, and earned a B.S. in Food Science from Clemson University where she also graduated cum laude.
CEO, Principal Consultant, FAS, Inc
Bio: Alyce Nelson was among the top rated speakers at the 2016 ASQ World Conference. She holds a bachelor’s degree in Mechanical Engineering from the University of California and a post grad certification from MIT in Cardiovascular Anatomy & Pathophysiology. She is a Certified Auditor, Clinical Monitor, a Professional Coach and Speaker, and an Energy Leadership Index Master Practitioner. She is a member of ASQ, the International Coaching Federation, the National Speakers Bureau, and is a decorated member of Toastmasters International. She has spent over 30 years in the medical industry with an initial emphasis on engineering and project management and a later emphasis on quality attaining the highest position of Vice President before beginning her own successful consulting and coaching practice. She currently works as a Quality Principal and Consultant to the medical device/bio-pharma industries, coaches Executives and High Potential Leaders, and works as a speaker, educator, and trainer.
Lead Consultant, Founder, QBD Strategies, LLC
Bio: Amy is currently the Lead Consultant at QBD Strategies LLC where she teaches and assists companies with approaches to implementing quality by design. She has 16+ years’ experience with biological research and development, working on purification, development, and characterization of viral vectors for gene therapy at Genzyme then later creating a product stream of protein characterization services for GlycoSolutions. Amy’s knowledge of biochemistry, mathematics, and cGMP requirements led to her belief that implementation of QbD can benefit the biopharmaceutical industry. She has spoken on the topic at the R&D 100 conference (“The Hurdles and Benefits of Designing Quality into Your Drug Product in Early Stage Development”, November 1015) as well as two publications on the subject in BioProcess Online.
President & CEO, Quality Support Group, Inc.
Bio: Angelo is President of Quality Support Group, Inc., an International Consulting and Training organization. Angelo has a B.S. in Chemical Engineering, M.S. in Manufacturing Engineering and a MBA. Angelo is a senior member of the American Society of Quality and member of the ASQ Audit Division (Webinar Chair).
Co-Founder, Co-Founder Boston Business Women Innovation Conference
Bio: Anna Tsui is an international serial entrepreneur, speaker, and writer. She runs Anna Tsui International, LLC., an executive leadership coaching company that provides transformative essential skills training for leaders and teams. Previously, Anna co-founded Wokaishi, China’s first interactive online fitness platform. She has been featured in The Boston Globe, Crunchbase, PreAngel, Technode, Agenda Beijing and more. She has worked with companies such as Gillette, State Street, PriceWaterHouseCoopers, Boston Police Department, New Balance, and The Venture Development Center.
President, The Innovation Outlet, LLC
Bio: Charlie Garland is President of The Innovation Outlet, an independent team of innovation and business strategy consultants; he is also a Senior Fellow at HITLAB (Healthcare Innovation & Technology Laboratory) @ Columbia University Medical Center. Charlie has helped drive innovation across a wide range of industries and organizations, including Financial Services, Professional Services, Healthcare, Education, Consumer Products, and more. He has developed an entire portfolio of novel innovation tools, methods, and logical models (Cognitive Buoyancy®, The Innovation Cube™, Value-Driven Thinking™, and more), working with business leaders to improve strategies, with doctors to reduce diagnostic errors, and with NASA to improve astronauts’ cognitive performance. Mr. Garland serves on the Board of Trustees of the Creative Education Foundation and is married to Pauline Turley, Vice Chair of the Irish Arts Center in New York City. Charlie, who grew up on Cape Cod, MA, earned his MBA from The Amos Tuck School of Business at Dartmouth College and currently lives and works in New York City.
Director, Boston Operations, Regulatory and Quality Solutions LLC (R&Q)
Bio: Christine Santagate is a Medical Device Quality, Regulatory, and Program Management professional with extensive experience in the medical device life cycle. This includes significant experience with the Design & Development Process, Design Quality, CAPA, and US/ International Regulatory approval. Christine has managed the development and market clearance of many medical devices, while providing coaching to internal staff. As a graduate adjunct instructor of Medical Device Development Regulations and Law at UMass Lowell, focuses on the quality and regulatory aspects of new product development with a heavy focus on risk management.
President, INQC Consulting, Inc.
Bio: David A. Manalan, President and founder of INQC Consulting, Inc., has over 45 years of experience with companies regulated by FDA, EPA, OSHA and similar agencies. During his first 21 years of work at Millipore Corporation, he was responsible for filter research, filter device development, manufacturing process improvement, quality systems development, and regulatory affairs. Over the past 24+ years as a consultant, he has worked with more than 45 companies, ranging from 5 to 50,000 employees. He has a degree in Chemical Engineering from the Massachusetts Institute of Technology and has done post graduate work in Biomedical Engineering at Northeastern University. David is a Fellow of the ASQ, a member of the Boston Section, an ASQ Certified Quality Auditor, Certified Biomedical Auditor, and Certified Software Quality Engineer. David currently chairs the Biomedical Division’s Awards-Scholarships-Grants committee.
President, Schmalensee Partners
Bio: Diane Schmalensee is an expert on customer experience management, strategic planning and performance excellence. She specializes in listening to internal and external customers, in strategic planning for competitive advantage and in helping clients execute their personal and organizational plans. She has helped organizations find profitable new directions through a combination of research, planning facilitation and operations improvement tools.
Ms. Schmalensee was an eight-time Examiner for the Malcolm Baldrige National Quality Award and a five-time Examiner and 25 year Board member of the Massachusetts Baldrige program group, Partners in Performance Excellence. She has served on the Boards of the Association for Consumer Research, the American Marketing Association, Nichols College, MassBay Community College, Boston Ballet and the U.S. Census, and was a Senior Member of the American Society for Quality.
She frequently speaks on performance excellence topics to associations such as The Conference Board, the American Marketing Association, and the American Society for Quality, as well as to executive education programs. Her publications include: Building Customer Loyalty, Corporate Reputation, and Shareholder Value through Service Quality Improvement, "Internal Customer Satisfaction" in Managing Service Quality, “Lessons Learned on our Quality Journey” in The Center for Quality Management Journal, “Unleashing the Power of Connecting Disciplines” in Reflections, “Measuring Returns on Research” in Marketing Research.
Before founding Schmalensee Partners in 1991, she was Vice President of the Marketing Science Institute, where she worked with academics around the world to conduct research important to business executives. She also served as Vice President of Opinion Research Corporation and in research for major regional advertising agencies.
She holds an MBA from San Diego State University and a Bachelor's degree from Wellesley College.
Quality System Manager, Generics Industry Leader, Clarkston Consulting
Bio: Dmitri Serebrianik is a manager with Clarkston Consulting. With the firm since 2015, he lends his expertise to leaders within Life Science companies in the areas of Quality Systems, Validation, M&A and Project Management activities. Dmitri has a passion for helping organizations deliver on their strategic goals. He has extensive experience with program management of complex business transformation efforts within quality and regulatory, mergers and acquisitions, and large enterprise technology implementations and deployments.
Dmitri received his MBA with a focus in Financial Engineering and M.S. in Pharmaceutical Management from Stevens Institute of Technology and earned a B.S. with a double major in Engineering Chemistry and Biochemistry from Stony Brook University.
Advisory Board Member, Veloxint
Bio: Dr. Donald Baskin is responsible for all items pertaining to materials engineering at a wind turbine OEM start-up called Ogin Energy located in Waltham, MA. This include items such as materials selection, joining, materials validation, specification creation, corrosion engineering, failure analysis and materials sourcing. Also, as materials and manufacturing are deeply intertwined, Dr. Baskin has been integrally responsible for Ogin’s manufacturing strategy. This includes stamping, stamping simulations, assembly, weld certification and design for manufacturability.
Prior to coming to Ogin, Dr. Baskin worked for a decade in the International Automotive Industry where he spent time at both Mercedes-Benz (Daimler) in Sindelfingen, Germany, and Chrysler in Auburn Hills, MI, USA. During this time, he held positions pertaining to every aspect of automotive body structure development. This included structural optimization (lightweighting), finite element analysis, structural materials development (both metals and composites), product design release, tolerance strategy (GD&T), and manufacturing (stamping, assembly, quality, etc.). This culminated in him attaining a supervisory rank, launching 7 vehicles into series production, publishing several articles and later a book chapter on body structure lightweighting.
Between Ogin and the automotive industry, Dr. Baskin worked at another start-up called Xtalic, which is an MIT spin-off commercializing nanocrystalline metals and coatings mainly for application in high-end electrical connectors used in mainframe internet servers. During this time Dr. Baskin was responsible for a team running customer focused applications development.
Dr. Baskin holds a Ph.D. in Materials Science and Engineering from Northwestern University and a B.S. in Mechanical Engineering from University of California, at Irvine.
Senior Industrial Engineer / Project Manager, ProcessZen Consulting
Bio: Fabrice is a licensed Industrial & Systems Engineer, facilitator and trainer with 18 years of experience managing improvement projects and teams. He founded Houston-based Process-Zen Consulting and his experience changing company culture and improving processes covers a broad range of industries including medical devices, pharmaceuticals, textiles and energy.
He is fluent in English, French and Spanish and has delivered training in the United States, Caribbean, Mexico and Latin America.
He is a published author and frequent conference speaker at world and regional conferences by the American Society for Quality (ASQ), The Project Management Institute (PMI), HR Houston and Universities and colleges in Texas.
General Manager, NQA
Bio: Jim is the General Manager of NQA, USA, a leading global certification body, where he is responsible for the overall management, administration and operation of the organization. Jim provides leadership in developing strategies for expanding the company’s ISO 9001, AS 9100 and other applicable standards, schemes and registration services. Jim is also a certified Aerospace Experienced Lead Auditor for both the AS9100 and AS9120 standards and has worked in the quality and management systems field for over 25 years.
Prior to joining NQA, Jim served as a Quality Engineer for Raytheon Company where he performed design and analysis of fixtures and assemblies for the Patriot Missile and associated missile test stations. Jim holds a Bachelor of Science in Mechanical Engineering from South Carolina State University.
Owner, Made to Thrive Consulting, LLC
Bio: Kirsten Smith, founder of Made to Thrive Consulting has over 20 years Business Development and Management experience with small and large organizations alike, including those listed among the Fortune 500. As a management professional with 20+ years working as a Manager of Sales & Marketing and then filling the role as Director of Business Development of quality & management systems, she is well positioned to help customers strive for excellence and accomplish goals.
Since 1990 Kirsten has given dozens of presentations to groups of all sizes. She is considered both a business professional and motivational speaker covering a range of topics including attitude change, effective sales techniques, customer service excellence, and personality profiling. Her desire to serve the community and inspire people in the workplace (and in life) drive her to share with her audience stories, examples and encouragement to empower the listener to step out of a comfort zone and embrace life with passion, driving peak performance and enabling them to thrive in challenging environments.
Adjunct Faculty - Organizational Leadership, Southern New Hampshire University
Bio: Kurt has over 20 years of experience within the quality and process improvement fields. He has a passion for finding creative ways to drive positive change. He is an ASQ senior member and is certified as a quality manager, quality auditor, and lean six sigma black belt. Kurt holds a doctorate in leadership as well as master degrees in philosophy and theology. By night, Kurt is an adjunct faculty member at Southern New Hampshire University, Ashford University, and the University of the Rockies. In this role, he tortures – teaches – graduate students about organizational leadership and corporate social responsibility.
Recent publications may be found in the Journal of Quality and Participation, the Open Journal for Business & Management, the ASQ Lean Division Newsletter, and the ASQ Audit Division Newsletter. Recent speaking engagements include the Lean and Six Sigma World Conference, the Quality Show, the ASQ World Conference, BOSCON, the NECQ, and more.
CEO, Actiview Analytics
Bio: Dr. Edelist is an advanced analytic solution’s architect with proven expertise in C-Level collaboration, business and data analysis. He has led many projects and teams in diverse sectors around the world including: financial institutions, government, telecommunications, high-tech, retail, manufacturing, and education. Additionally, he has developed a unique process for the architecture and creation of advanced analytic solutions. He and his teams leverage relevant best of breed business processes, coupled with relevant best of breed technology, creating solutions that deliver performance excellence. These solutions are driven by C-level officers and delivered by their business teams.
Liran Edelist is the CEO of Actiview Analytics LLC, a subsidiary of Actiview with over 100 experts of business analytics and performance management.
Consulting Engineer, Quality Consultings Inc
Bio: Dr. Mohammad Pourgol-Mohammad is a safety/reliability analyst in multidisciplinary systems analysis with Quality Consultings Inc. and an Associate Professor of Reliability Engineering, with Sahand University of Technology (SUT), Tabriz-Iran. He received his Ph.D in Reliability Engineering from University of Maryland (UMD), and holds one M.Sc degree in Nuclear Engineering and another in Reliability Engineering from UMD. His undergraduate degree was in Electrical Engineering. Dr Pourgol-Mohammad has more than 15 year of work experience including research and teaching in safety applications and reliability engineering at various institutions including FM Global, Goodman Manufacturing, UMD, Massachusetts Institute of Technology (MIT), International Atomic Energy Agency (IAEA), University of Zagreb-Croatia, USNRC and INEL. He is a senior member of ASQ, ASME, IEEE (2008-2010) and ANS and member of several technical committees and a registered Professional Engineer (PE) in Nuclear Engineering in States of Maryland and Massachusetts. He is a certified reliability engineer (ASQ CRE). He has authored more than 80 papers and reports on his researches. His efforts have been appreciated with several awards and recognition.
Associate Partner and Watson Leader, IBM Global Business Services
Bio: Mr. Frangoulis is IBM’s North American leader for Industrial Cognitive Business Solutions. In this role, he helps clients across the Industrial portfolio to optimize operations and create new revenue streams leveraging Cognitive and Analytic technologies. Mr. Frangoulis has 25 years of experience in business and technology consulting. In 2016, he was one of only 52 IBM’ers in North America to be named a “Best of IBM” honoree. Mr. Frangoulis is currently engaged in several high profile cognitive pursuits. He lives in Atlanta, GA with his wife of 30 years and children.
Principal Engineer, Regulatory and Quality Solutions
Bio: Pooja Roychoudhury is a Principal Engineer at Regulatory and Quality Solutions (R&Q) and possesses over 12 years of industry experience working with Class I, II, and III medical devices. She utilizes her unique background in software, PEMS, design assurance, risk management, usability, quality and regulatory to provide R&Q clients with solutions to challenging problems, while balancing business objectives and regulatory compliance. Pooja has extensive knowledge of Design Assurance functions including Test Methodologies and Strategies development for Medical Devices per FDA guidelines and Risk Management function including devising Safety Risk Management Plans, conducting hazard analysis, preparing Safety Risk Management Summary Reports, conducting Risk-Benefit Analysis, etc. She possesses extensive leadership in human factors and usability testing. Pooja has also developed Quality Management System (QMS) for several medical devices (electromechanical, PEMS, and software only) so she is both strong technically and process oriented. To round out her knowledge, Pooja has prepared and submitted several 510(k) submissions to the FDA and third party reviewers. She has also exceptional skill-set in partnering with Program Managers and aligning departmental objectives with program objectives. She is Six Sigma green belt certified and possesses 3 Masters (MS) Degrees along with Bachelors in Industrial Engineering.
Lean Six Sigma Master Black Belt Consultant, Quality Support Group
Bio: Lean Six Sigma Master Black Belt with +20 years deploying Lean Six Sigma programs, Billions in $ saved. owner of the LinkedIn Lean Six Sigma Group on LinkedIn, Author, Speaker, Trainer.
Director, NQA, USA
Bio: Tim has worked in the quality and management systems field for over 20 years, honing his expertise in ISO 9001, ISO 14001, ISO 27001, ISO 22301 and related disciplines through that period. As a certified management systems lead auditor he has led and participated in hundreds of third party audits for organizations in the ICT, transportation, finance, manufacturing and service industries around the world. Additionally, Tim serves on various industry groups charged with developing and overseeing international management system standards and oversight of third-party certification to such standards.
This hands-on experience combined with an MBA from the University of Massachusetts have laid the foundation for Tim’s present role as Business Unit Director at NQA, a leading global certification body. In this role, he is presently responsible for the roll out and implementation of NQA, USA’s ISO 9001:2015 Transition Program including the oversight of nearly 4,000 certifications in the Americas and integration of NQA’s 30,000+ certifications globally.
Aerospace Business Unit Director, NQA
Bio: Bob Parsons is the Aerospace Business Unit Director for NQA, and is an active participant in the American Aerospace Quality Group (AAQG), the International Aerospace Quality Group (IAQG) and the Registrar Management Committee (RMC) which are the groups supporting the aerospace series of standards. He is also responsible for training the NQA aerospace auditors on both the new and existing AQMS standards, educating the NQA customer base on these new standards to include our interpretation of any new requirements and ensuring NQA’s adherence to various international standards that govern aerospace such as AS9101, AS9104 and ISO17021.
Prior to joining NQA, Bob was active duty in the US Navy as a Naval Aviator. He has flown many types of military aircraft with many of those flight hours coming as a functional test pilot. In addition to his flying duties, he has been the officer in charge of the avionics, aviation electronics, jet engine, structural/hydraulic and quality assurance divisions in the various squadrons in which he was a pilot.
Quality Assurance Manager, CCL Label
Bio: James August is a quality professional with over thirty years’ experience in commercial, industrial and military/aerospace manufacturing. He holds a Bachelor of Engineering and a Masters in Materials Science from SUNY Stony Brook. Currently, Jim is Quality Assurance Manager for CCL Label (Robbinsville) where he is working on integrating ISO 9001, GMPs and Lean Manufacturing into a single business quality management system that spans five separate plants.
As a Senior member of ASQ, Jim belongs to the Princeton and South Jersey Sections. He is an ASQ Certified Quality Auditor since 1993 and a Certified Manager of Quality/ Organizational Excellence since 2008. Jim was active in Quality New Jersey between 1991 and 2007. Mr August has taught courses at Rutgers, Raritan Valley Community College and Middlesex County College. More recently, Jim has been a workshop leader and trainer for ISO 9001 and ASQ CMQ/OE and CQE certification refresher courses. Jim has a wide range of professional interests and is often a guest lecturer at Rutgers in addition to being a regular presenter to ASQ local Sections and ASQ regional programs.
Bio: Barry Craner was Vice President of QA/RA at Stellartech Research Corporation, has Masters degrees in Science and Business (with Distinction), an equivalent minor in electrical engineering, multiple certifications by ASQ, Regulatory Affairs Certified by RAPS, Past Chair of the ASQ Biomedical Division (2007-2008), the ASQ San Diego Section (1987-1988), and three times Chair of the ASQ Biomedical Northern California Discussion Group (2005, 2014, 2016). Barry is adjunct Professor in the MSQA program with the California State University (10 years), Instructor for UC Santa Cruz Extension, teaching Risk Management at the graduate level (9 years). In 2008, Barry received the Simon Collier Quality Award by Los Angeles ASQ Section, in 2010 the Marvin Rosenbaum Distinguished Service Award by the ASQ Biomedical Division, and in 2015, the ASQ Biomedical Division established the Barrett C. Craner scholarship for young QA practitioners.
Bio: Ms. Coutu holds a Bachelor of Science degree in Environmental Science and Economics and is currently pursuing her Masters and Doctorate degree in Sustainability with a focus on infrastructure resilience. She has more than 18 years of experience in business management, strategic planning and compliance and has served in different capacities as a manager in support of major infrastructure projects for MassDOT and MBTA and other Railroads. Ms. Coutu has actively participated as a member for recognized organizations such as the New England Water Environment Association, Society of American Civil Engineers, Local Emergency Planning Commissions, Women in Transportation Seminar, amongst other. In her leadership role for Keolis, she manages the development and implementation of environmental compliance programs and Environmental Management System following ISO 14001 standards for the Commuter Rail. In her tenure, she has championed the implementation of programs for the management of Spill Prevention Control Countermeasures Plans for six facilities, NPDES Stormwater Pollution Prevention Plans for eleven facilities, RCRA Hazardous Waste Management for 24 facilities, and the implementation of systems to ensure the compliance of more than 230 permits that cover compliance with Federal, State and local authorities for ROW infrastructure, drainage systems, tank and fueling systems, GHG and CO2 emissions, Waste Water Treatment, amongst other. In her first 12 months, Ms. Coutu has succeeded in defining strategies for the implementation and execution of the first Environmental Management System following the ISO 14001 standards and achieving the first certification for a New England railroad and for Keolis Internationally. Ms. Coutu holds professional training as an ISO 9001 Internal Auditor and Green Belt and holds a certificate for Lead QMS Auditor for Integrated Management Systems [Certificate No. 10115 from Exemplar Global AU2364/TL2368], amongst other.
Bio: Daniel J. Fleming is GBMP's Director of Consulting Services & a Certified Shingo Institute Workshop Facilitator.
He is a Shingo Prize Recipient & SME Lean SILVER Knowledge Certified. Dan brings 30+ years of experience in operations and engineering to GBMP including more than 25 years of hands-on experience learning, leading and teaching the principles and tools of the Toyota Production Systems and continuous improvement.
He was the lead developer of GBMP’s highly regarded Lean in Healthcare Certificate Course. This comprehensive program was one the first of its kind in healthcare. Over the past five years Dan has been the lead faculty on programs taught at more than 30 hospitals, medical clinics and nursing homes. More than 600 students have gone through the program, including clinicians, hospital and nursing home staff, and architectural professionals. Dan has been an inspiring and informative speaker at many regional, national and international conferences. Prior to becoming the Director of Consulting Services, Dan was a Continuous Improvement Manager at GBMP for 14 years. Dan was the Director of Operations at United Electric Controls Company, where he was a recipient of the Shingo Prize for Operational Excellence. He has worked with a wide range of organizations including healthcare, electronics, medical device, pharmaceutical, equipment manufacturers, food processing, machine shops, contract manufacturers, and warehouse and distribution. Mr. Fleming holds a Bachelor's Degree in Electrical Engineering Technology from Northeastern University.
Bio: Diane Shay’s background includes experience in combination product design assurance, supplier management, and post market surveillance. Diane has managed new product development design assurance activities from early-stage development through full multi-national commercialization, with success in startup companies such as Atrum Medical and Insulet Corporations as well as larger companies such a Haemonetics and Millipore Biopharmaceuticals Division.
Boscon Chair, ASQ Boston
Dr. Nicco Krezdorn
Bio: Nicco Krezdorn, M.D., is a physician-scientist currently pursuing a post-doctoral research fellowship at the Division of Plastic Surgery at Brigham and Women's Hospital and Harvard Medical School in Boston. He is a reconstructive plastic surgeon in training with strong interest and focus on reconstructive and restorative transplantation. For his research on extremity preservation he uses modern technologies and close collaboration with the MIT to push the limits of current standards of care further.
Additionally he has a keen interest in quality aspects of education and training for physicians and quality of life for healthcare providers, where he is providing coaching, workshops, talks and trainings on a national and international level.