Tim Philips
Specialist
M: 715.821.8127
Tim Philips is a quality assurance and regulatory affairs professional with over 30 years of experience in commodities regulated by the U.S. Food & Drug Administration (FDA). He is an expert and instructor in FDA law / regulation, quality systems, inspections, evidence development, enforcement actions, and product recalls with an emphasis on post-market compliance of medical devices.
Representative Experience
• Regulatory
• Quality
• Enforcement
• Quality System (a.k.a. GMP) assessments, investigations, and training
• Resolving FDA Warning Letters, Untitled Letters, and “Form 483” Inspectional Observations
• FDA “Regulatory Meetings”, information requests, and inspections
• Product field actions (e.g., corrections/removals, recalls, safety alerts)
• Mitigation and remediation of FDA enforcement actions
• Mock FDA audits
Education
• Bachelor of Science, Biomedical Engineering (1986), University of Iowa – Iowa City, Iowa
Bar Admissions and Qualifications
• Assisted in the development of FDA’s original device investigator certification program and served as a performance auditor to evaluate candidates in the program
Memberships
• American Federation of Government Employees, Local 3381 – Chief Steward
Faculty Appointments
• Adjunct Professor at the University of St. Thomas (St. Paul, MN) in the Regulatory Science Program in the School of Engineering