Senior Professional Services Consultant, MasterControl
Chris Ball is a Senior Professional Services Consultant at MasterControl. Prior to MasterControl, Chris had a diverse career in quality assurance and quality improvement in GLP, GCP GMP and ISO environments in the Agrochemical, Contract Research Medical Device and pharmaceutical industry sectors.
Chris has been on MasterControl's front line form nearly six years, working with QAAD users. "Meeting with customers allows me to better understand the individuals using our products their needs and personalities which enables me to provide a better service," he says. "I'm looking forward to this year's Summit because it is a great opportunity to meet the clients in a wonderful environment."
Professional Services Consultant, MasterControl
Troy Baxter is a Professional Services Consultant with five years' experience at MasterControl. During those five years, he's worked closely with customers, using their feedback to help improve MasterControl's products. "Working with MasterControl customers has taught me best practices for configuring and using a Quality Management System," Troy says. "I'm looking forward to this year's Summit because I will be able to share valuable information with customers about better ways to use MasterControl."
MasterControl Product Manager, Blood and Biologics Expert
Rob Carpenter has worked more than 16 years in the eye, tissue and blood banking industry, most recently as the Director of Tissue Processing for Community Blood Center/Community Tissue Services in Dayton, Ohio. During his tenure, he worked with various medical device companies to bring 13 new grafts to market.
As an active member of the American Association of Tissue Banks (AATB), Mr. Carpenter serves on both the Education and Program Committees and as a course director for the AATB's Certified Specialist Training and Review Course. He is a recognized speaker at blood and tissue conferences across the country. Mr. Carpenter holds a BS degree in Biological Sciences from the University of Cincinnati and a certificate in Project Management from Xavier University.
Educational Services Group Manager at MasterControl, Inc.
Jonathan Crowther develops comprehensive, easy-to-use-and-understand instructional materials for worldwidedistribution to a diverse community of users serviced by MasterControl's US, UK and Japan offices. Mr. Crowther also travels extensively to help clients configure their off-the-shelf applications to meet specific client needs while complying with the requirements of all relevant regulatory groups.
Mr. Crowther has a MEd in Instructional Technology from the West Chester University, and a BS degree in Industrial Education from Cheyney University. He also has a number of technology-related certificates with Microsoft (MCSE), Microsoft Training certificates, and is certified in Microsoft SQL/VB programming. Mr. Crowther is an active professional member of ASQ and is certified as a Lead Auditor and Certified Auditor (CQA). He currently holds three patents within the medical device industry and has two devices on the public market.
Professional Services Consultant for MasterControl QAAD™, MasterControl Inc.
As a Professional Services Consultant based in the UK, Linda Francis provides MasterControl QAAD™ clients with continued support. This involves helping customers to understand how their processes can be maximised using QAAD, and making sure that all their questions, issues and concerns are responded to and/or resolved in a timely and efficient manner.
Ms. Francis joined AMGIT Systems in 2006, just before the company was acquired by MasterControl. She graduated from Manchester University with a BSc in Business Information Technology, and feels that this training has helped her in her current position on many different levels. For example, on an analytical level, on the level of being able to provide enhanced support and training services, and on the level of promoting her continued growth in her chosen field.
MasterControl Product Manager, Pharmaceutical Industry Expert
Lane Hirning is a pharmacologist with extensive IT experience in the pharmaceutical industry. He started his career as a research scientist at NPS Pharmaceuticals Inc. After seven years, he moved into an IT function, serving over a span of 12 years as IT Manager, IT Director, and Senior Director of Research IT.
Since joining MasterControl in 2006, Dr. Hirning has specialized in product development for the pharmaceutical industry, with an emphasis on regulatory and other requirements for clinical teams. He has a bachelor's degree in pharmacy from Idaho State University and a PhD in pharmacology and toxicology from the University of Arizona. He served as a post-doctoral fellow at the University of Chicago's Department of Pharmacology and Physiological Sciences. Dr. Hirning actively participates in industry events, such as seminars and workshops on computer system validation, lab informatics, and pharmaceutical development.
Senior Product Manager, MasterControl
Dave Hunter is a Senior Product Manager with more than 15 years' experience in software with such industry giants as Microsoft, EDS, Intel and TenFold. He's worked in product development with MasterControl for eight years and holds a BS in electrical engineering and a MBA, both from Brigham Young University.
Process Consulting Services Team Lead, MasterControl Inc.
Lance Johnson, employed by MasterControl since 2005, travels extensively throughout the country as a consultant. He works closely with customers in defining, mapping, designing, and optimizing critical electronic business processes to replace manual systems and has implemented over 200 software projects.
Previous to MasterControl, Mr. Johnson worked as a Document Control Manager for a microbiology laboratory and as a Software Quality Assurance Engineer for a telecommunications software company. His FDA- and ISO-experience, combined with his technology background, give him a unique perspective on process engineering and management. He holds a BA degree from Brigham Young University.
Quality Assurance Engineer – Team Lead, MasterControl
Jim LeBaron is a Quality Assurance Engineer – Team Lead in MasterControl's Quality Assurance department. He's worked in QA at the company for three years, managing a team in Pakistan and part of the QA team in Salt City. He holds a BS in Information Systems and a BS in Marketing from the University of Colorado, Colorado Springs.
Jim says the Summit gives him a chance to meet new customers. "Meeting with customers allows me to understand how they use MasterControl and customize my testing to capture that. It's also taught me the importance of easy-to-validate software!"
|Matthew M. Lowe|
Executive Vice President
Medical device expert Matt Lowe joined MasterControl in 2006. Since then, he has served MasterControl as a Product Manager and Senior Vice President. His career includes product development and product management at Ortho Development Corp. and at Bard Access Systems. Lowe has successfully launched more than a dozen medical devices. He has four patents issued and two others pending. His regulatory experience includes writing a 510(k) that was cleared by FDA and managing a multi-site, multi-year post-market clinical study for orthopedic devices. Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.
Founder & President, Axendia
Daniel R. Matlis is a trusted advisor to life-science executives on business, technology, and regulatory issues. Danâ€™s 18-year experience in the life-sciences industry has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.
Prior to founding Axendia, Dan was vice president and general manager at Stelex, Inc. â€“ a leading consultancy to life-science companies. He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.
He holds degrees from both Polytechnic University (BS in electrical engineering) and New Jersey Institute of Technology (MS in management). Dan is the chief contributor and editor of Life-Science Panorama â€” a publication covering business, regulatory and technology issues facing industry executives.
MasterControl Quality Management Architect
Ken Peterson is a Quality Management architect with a strong background in both the life sciences and engineering. He has over 25 years of experience in consulting and organizational change, quality management, and product development. His responsibilities at MasterControl Inc. are to enhance the Quality Management System solution product offering and incorporate best practices for managing CAPA within the MasterControl client solution.
Currently Mr. Peterson is Chairman of Board of Directors for Intermountain Biomedical Association (IBA) and on the Board of Advisors for the Utah Technology Council (UTC). He works closely with FDA and business to drive growth and build lasting partnerships.
Prior to joining MasterControl in 2008, Mr. Peterson served as the CEO at PathWise Inc., an education and consulting firm that specializes in compliance and process management. Prior to his 15-year tenure at PathWise, a company which he founded, Mr. Peterson was with Pfizer Corporation, where he obtained a rich understanding of both the pharmaceutical and medical device industries. The areas in which he was involved include customer service, product development, marketing, delivery, quality systems (specifically CAPA and risk management), sales systems, and policy changes. He has successfully solved hundreds of quality problems from high impact CAPA investigations to installing better quality management systems.
Mr. Peterson graduated from Brigham Young University in Provo Utah in 1981, and was one of the founding members of the College of Entrepreneurship at Brigham Young University. He speaks annually at such organizations as AAMI, PDA, the American Society for Quality, Barnett International, The Executive Committee (TEC), and other industry forums.
Sr. VP of Marketing, MasterControl Inc.
Curt Porritt has more than 18 years of experience in the high-tech industry, including more than 13 years of upper-level management experience. He played an integral part in designing and managing WordPerfect's international development organization â€” one of the first in the world to produce software products simultaneously in more than 30 different languages. In 1995, Mr. Porritt began his own consulting firm that helped clients achieve the highest possible ROI from their international markets.
Prior to joining MasterControl in 2006, Mr. Porritt served as President and CEO of 10x Marketing, an Internet marketing firm focused on helping companies bring more visitors to their Web site. As Senior Vice President of Marketing for MasterControl, he has merged his international experience with the latest breakthroughs in global Internet marketing. Mr. Porritt enjoys teaching classes on Internet marketing and business strategy for the Small Business Development Center based on a book he authored entitled The Basics of Business.
MasterControl Manager of Validation Services and Solutions Group, Software Validation Expert
Louis Rutledge has almost two decades of experience in process engineering, document control implementation, software configuration management, and quality management systems. He has worked for the U.S. Department of Defense and in the medical, general manufacturing, and telecommunications industries. As Director and Quality Systems Manager of the Product and Release Department of 3Com / US Robotics Residential Products, he was responsible for the lifecycle development, product realization, design team management, and controlled release of more than 200 projects in multiple product lines. Since joining MasterControl in 2001, Mr. Rutledge has led software implementation and validation projects for more than 150 customers in the United States, Canada, and the United Kingdom. His expertise includes validation protocol development, ISO 9001:1994, ISO 9001:2000, ISO13485, TL9000, QS9000, 21 CFR Parts 11, 210-211, 606, and 820. He also has expertise with Q7A, the Capability Model (CMM/CMMI) for Software Development, as well as ANSI, IEEE, and BABT specifications. Mr. Rutledge has a technical degree in electronics from the U.S. Navy and lead auditor certifications for ISO 9000 and TL9000 quality standards. He is an active member of the American Society for Quality, ISPE, and the CMU SEI SEPG communities.
Senior Professional Services Consultant, MasterControl Inc.
Dondi Vance is a MasterControl product expert/consultant in the areas of product configuration and implementation. She provides customers in a variety of regulated industries with best practice product knowledge and the experience necessary to ensure a successful project implementation. Ms. Vance also designs and creates product training materials and conducts administrator courses. She is highly skilled in several MRP/PDM applications, including, in addition to MasterControl, SAP, Baan, and Agile.