James R Stephen – President

Jim has over 24 years of experience in the laboratory and over 15 in the pharmaceutical and medical device industries. During his career he has been part of the start-up teams for several facilities as well as provided on-going support for existing operations. As a Microbiologist, he has expertise in environmental monitoring, clean room operation, aseptic manufacturing, media fill protocols and terminal sterilization.

GARTH ANDERSON – Sr. Validation Consultant

Garth has over 12 years of experience in engineering services, validation, and GAP analysis of pharmaceutical equipment, utilities and manufacturing processes. He is an expert in developing and implementing Installation, Operation, and Performance Qualification protocols. He has a broad range of experience extending from Lyophilization and equipment validation to Validation master planning and project management.

MANFRED POLK - Sr. Validation Engineer

Manfred has over 15 years of experience in engineering services, validation, and GAP analysis of pharmaceutical equipment, utilities and manufacturing processes. He has extensive experience in clean room design and validation, FDA 483 and warning letter responses, as well as Installation, Operation, and Performance Qualification protocols for equipment and production processes.