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 in various positions in 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 one patent 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 the 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 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.