Key Personnel
Ken Edwards
Director, Business Development
Mr. Edwards has over twelve years experience in the bio/pharmaceutical industry with a background in validation management, engineering project management, and facilities, utilities, process and computer validation. He offers expertise in the development, implementation and management of Quality Systems and cGMP Validation of Biological manufacturing processes and environmentally controlled stability chambers.
Mr. Edwards is co-founder of Concentric Inc. a validation consulting company specializing in utility, equipment, and stability chamber validation services to the biotech and pharmaceutical industries.
Mr. Edwards is a member of AAPS, AALS, PDA and serves on the ISPE Carolina-South Atlantic Chapter Vendor Committee.
Ross Hile
Engineering Manager
Mr. Hile has over thirty years experience in manufacturing, design, and servicing of precise temperature and humidity controlled rooms and chambers. During this period he has worked with many customers within the pharmaceutical industry by providing and maintaining stability storage rooms and chambers.
Mr. Hile is co-founder of Parameter Generation & Control, Inc (www.humiditycontrol.com) a company that specializes in the production stability rooms and chambers.
Phil Clark
Validation Manager
Mr. Clark has over ten years of experience working in the pharmaceutical industry with a focus on metrology and the validation of environmentally controlled chambers and laboratory instruments. The majority of his career was spent at the North American Stability Hub of one of the industry leaders where he was solely responsible for the validation, calibration, maintenance, and repairs of all stability chambers, laboratory refrigerators, and laboratory freezers resulting in 0 hours of downtime for 5 consecutive years. He is adept in CFR 21 Part 11 and cGMP principles and proficient in writing and executing validation protocols, developing departmental SOPs, and in training end-users in equipment operation and maintenance.
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