ATV exists to provide high quality, cost effective Validation, Commissioning and Technical Consulting services to the Biotech, Pharmaceutical, Medical Device and Diagnostics industries in the GMP arena.
People who work in the GMP field know that it is a tightly knit community, where everyone seems to know everyone else and people keep track of each other. Prior to starting ATV, Rich Yeaton spent eight years establishing and growing East Coast Validation Services. After a one year stint of being acquired by a larger company, Rich returned to self employment in September 2014 as ATV. Before starting and growing East Coast Validation Services, he spent ten years establishing and growing Phoenix Imperative, Inc, first in Newark, Delaware and then in Portsmouth, New Hampshire. ATV is dedicated to developing and growing professional relationships in the GMP field.
Rich Yeaton, Owner of Atlantic Technical and Validation Services
Rich Yeaton is the owner of Atlantic Technical and Validation Services in Derry, NH and has more than 25 years' experience working in FDA regulated industries. He was initially introduced to GMP operations on the Devices side as a Development Engineer in DuPont's Medical Products division, where he developed and improved new process equipment, and then was told to validate what he had designed. He moved on to help start Phoenix Imperative, an Engineering and Validation consulting company serving the BioPharm industry. A key achievement with Phoenix was leading validation teams to assist MedImmune to obtain its first two commercial licenses. He has since worked with small startup companies and larger operating companies such as Shire, Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and startups. He recently assisted Avecia Biologics, a microbial fermentation Contract Manufacturer, to successfully prepare for their first Pre Approval Inspection. He is currently working with a GMP Operating company to manage the renovation and subsequent validation of a pharmaceutical manufacturing facility for a Phase III Clinical product. He is a member of ISPE, PDA and AAMI and has degrees in Electrical Engineering and Mechanical Engineering from Lehigh University.
Christine Kielhorn, Director of Quality
Christine Kielhorn is Director of Quality for Atlantic Technical and Validation Services and has a Ph.D. in Biomedical Engineering from the Georgia Institute of Technology and Emory University. She has recent experience developing a Process Validation protocol for a Drug Delivery product that is surgically implanted into the eye to deliver API over an extended period of time. She also has recent experience providing Scientific and Quality Assurance support for an API microencapsulation train as well as a production scaleup effort for an oligomer production process.
Before joining ATV Services, Doctor Kielhorn led the Quality Control laboratory for SiO2 Medical Products in Auburn, AL. In this role, she addressed particle testing of silica coated plastic vials and syringes for both subvisible and visible particles. She is a member of PDA and AAMI.
Kelly Thomas, Vice President of Quality Assurance
Kelly is a highly experienced Quality Assurance / Quality Control / Regulatory Compliance Manager with experience in API, biotech, aseptic, medical device, solid-dose, contract manufacturing and terminally sterilized manufacturing processes. Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, implementing Lean and Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams. She has a high degree of quality understanding and ability to apply knowledge of regulatory requirements particularly with process / equipment validation, lot / process investigations, quality systems, quality control, data trending, laboratory equipment and validation. She is experienced with facility start-up and PAI inspections. She has a highly successful regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, and ANVISA. She has experience working with SAP and CMMS systems.
Kelly is a goal-oriented and self-motivated professional who is committed to quality, teamwork, continuous improvement and organizational success. She is a recognized Subject Matter Expert (SME) on Environmental Monitoring and Trending, with an emphasis on Contamination Remediation and Risk Management.