Timothy J. Fields
GMP and Quality Assurance
Tim has over 27 years of experience in the pharmaceutical industry including 13 years with Pfizer where he was responsible for organizing and managing the corporate software quality assurance audit program, developing GMP training programs for management level personnel, and conducting numerous internal and external quality audits. Mr. Fields experience includes sterilization validation, aseptic processing, computerized system validation, process validation, cleaning validation, GMP training, 21CFR Part 11, document management, calibration and auditing. He is also familiar with worldwide regulatory GxP requirements as well as in the development of policies, procedures, and quality standards based on such analyses. Mr. Fields is a member of ISPE, PDA, ASQ, and GAMP Americas. He has published and lectured worldwide on various compliance-related topics including computer-related system validation, electronic signatures and records, document management, validation, SOPs, and GMPs. Mr. Fields is a member of the Editorial Review Board for the Journal of GXP Compliance. He is an adjunct instructor at the Community College of Rhode Island, where he teaches Introduction to Pharmaceutical Compliance.
B.A. Biology - Indiana State University
M.A. Life Sciences - Indiana State University.