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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES


Kirk Mousley, Ph.D.
Clinical Trial
Data Processing

Mousley Consulting, Inc., President and Software Consultant

Clients include Merck, Centocor, Children’s Hospital of Philadelphia

Developed system for clinical trials data collection, Electronic Data Capture (EDC)

Oracle-based edit-check application

Preparation of electronic FDA submission materials

Provide assistance in complying with GCP and 21 CFR 11

Liberty Technologies, Leeds and Northrup, At&T Bell Labs, Rabbit Software, GE – Designed and implemented broad range of computer systems and programs for variety of uses

Academic Achievements

Computer Science – Ph.D. Lehigh University

Electrical Engineering – B.S.E.E. and M.S.E.E., Massachusetts Institute of Technology