Dennis E. Guilfoyle, Ph.D.

Presently, I am a Senior Director, Microbiology & Analytical Regulatory Compliance with Johnson & Johnson Corporate Compliance and Quality Control. However, for the past 40 years, I was employed with the U.S. Food & Drug Administration (FDA) and was classified as an international expert in the field of pharmaceutical microbiology. I had conducted on-site manufacturing reviews of pharmaceutical/medical device/biopharmaceutical processing and prepared in-depth reports. I had evaluated microbiological GMP problems associated with laboratory and production activities along with validation reports relating to FDA483 observations, EIRs and warning letters. Conducted risk assessment of objectionable microorganisms isolated from pharmaceutical drug, biopharmaceutical, medical device, and tissue manufactured products. I had periodically provided expert counsel and declarations for FDA General Legal Counsel in association with testimony in FDA civil and criminal court cases. I had participated in the development of FDA CDER/CBER guidance documents, policies and regulations. I had served as an instructor on several FDA national training cadres. I have been a member of the USP expert committee for Microbiology and Sterility Assurance for the last 15 years. In addition, I have been an associate professor at a major university teaching two classes entitled; current GMP and Process Validation for the manufacturing of pharmaceutical products and medical device.