MasterControl Industry and Subject Matter Experts

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, Hirning has specialized in product development for the pharmaceutical industry, with emphasis on regulatory and other requirements for clinical teams. He has a bachelor’s degree in pharmacy from Idaho State University and a Ph.D. in pharmacology and toxicology from University of Arizona. He served as a post-doctoral fellow at the University of Chicago’s Department of Pharmacology and Physiological Sciences. Hirning actively participates in industry events, such as seminars and workshops on computer system validation, lab informatics, and pharmaceutical development.

Matt Lowe is a mechanical engineer with almost a decade of experience in the medical device industry. At Ortho Development Corp., he developed instruments and implants for total knee arthroplasty. Later, he served as the knee-product manager. Prior to joining MasterControl in 2006, he was a product manager at Bard Access Systems, where he was responsible for strategic marketing of enteral feeding products. He also served as an R&D engineer and developed subcutaneous infusion ports and related procedural components for Bard. Since 2000, Lowe has successfully launched more than a dozen medical devices. He has two patents issued and two others pending. His regulatory experience includes writing a 510(k) that was cleared by the 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.

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, Rutledge has led software implementation and validation projects for more than 150 customers in the United States, Canada, and 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, Q7A, the Capability Model (CMM/CMMI) for Software Development, as well as ANSI, IEEE, and BABT specifications. 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 CMU SEI SEPG communities.

Trained in biological sciences, information technology, and business administration, Oliver Wolf has more than a decade of experience in information systems and computer validation in the pharmaceutical and software industries. He started his career at Cephalon Inc. (formerly Anesta Corp.), where he served first as a laboratory technician, and eventually, as IT manager. He held several consulting positions at Pfizer, Amgen, and Eli Lilly, in automation engineering, software validation, and project management. He joined MasterControl in 2004, first as a computer validation consultant, and then as a product manager. Wolf earned a double bachelor’s degree in biology and environmental studies magna cum laude from Tufts University. He has an MBA, with an emphasis in information technology, from the University of Utah. His expertise includes database theory and design, software development lifecycle methodologies, project management, computer validation methodologies, and pharmaceutical manufacturing processes.

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 thirteen new grafts to market.

As an active member of American Association of Tissue Banks (AATB), 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.

Carpenter holds a Bachelor of Science degree in Biological Sciences from the University of Cincinnati and a certificate in Project Management from Xavier University.

Bethany Ebling is a Quality Assurance professional with more than 20 years of FDA experience within various pharmaceutical, biotechnology, and medical device companies.

She has been a Quality Assurance Manager with Human Genome Sciences, as well as Quality Engineer with Watson Pharmaceuticals, and General Electric Healthcare. She gained laboratory management experience at Mountain States Analytical Laboratories, ACZ Laboratories and Lancaster Laboratories. Her extensive professional expertise ranges from creating new CAPA processes, to serving as a lead auditor and a member of a laboratory management team. Ebling has an in-depth knowledge of cGMPs, FDA regulations (CDER, CBER, CDRH) and ISO regulations. She is skilled in SAP, ETTS, and LEAN Manufacturing.

Ms. Ebling holds a B.S. from Purdue University and is a Senior Member of ASQ as a Certified Quality Auditor (CQA). She is a member of the Regulatory Affairs Professional Society (RAPS) and the National Capital Area Regional Society of Quality Assurance (NCARSQA).

Bill Wolenchuk is an electro mechanical designer with almost a decade of experience in the medical device industry. Prior to joining MasterControl in 2008, he was with Endologix Inc., where he was instrumental in guiding the R&D and Manufacturing Engineering departments in the development of an abdominal aortic aneurysms (AAA) device, then obtaining FDA approval for the device. Mr. Wolenchuk was also the Document Control Manager, responsible for the compliance, control and distribution of all documentation, including the review of engineering documentation for manufacturability. Prior to joining Endologix in 1999, he was an Engineering Services Manager for Optical Disc Corp., a world leader in the development of compact disc and DVD mastering equipment. As a design consultant for more than 20 years in the commercial and aerospace industries, he worked on such projects as the B2 Stealth Bomber, DIVAD tank, AAH Attack helicopter and commercial and military communication satellites.

Ken Peterson is a Quality Management Architect with a strong background in both life sciences and engineering. He has more than 25 years' experience in consulting and organizational change, quality management and product development. His responsibilities at MasterControl Inc. include enhancing the Quality Management System solution product offering and incorporating best practices for managing CAPA within the MasterControl client solution.

Currently Mr. Peterson is Chairman of the 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.

Before 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.