CDR Kristen D. Evans has served in the Commissioned Corps of the US Public Health Service since 1986. He has been an investigative engineer with the Food and Drug Administration since 1987 in the Newark, Atlanta and Philadelphia Districts. He conducts pharmaceutical and medical device inspections worldwide, specializing in sterile manufacturing operations. He has published several papers and frequently presents on the topics of validation and sterilization qualification. He is a member of the FDA Aseptic Processing Guideline Revision Workgroup, and serves on the Editorial Advisory Board for the Journal of GXP Compliance. Since 1999, he has collaborated with Dr. Irving Pflug, a world-renowned leader in the sterilization arena, on several projects, including teaching a course entitled, The Microbiology and Engineering of Sterilization Processes. Mr. Evans received a degree in Biomedical Engineering from Duke University in 1987.
*FDA representatives are participating in their private capacity, and no endorsement by FDA is intended or inferred

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