Back to: FDA Compounding Quality Center of Excellence Annual Conference 2025
About:
Discover the essential facility design elements to control environmental parameters, such as temperature, humidity and pressure. This presentation will be followed by a panel of outsourcing facilities to share challenges and considerations on setting up their facility and quality systems.
Presenter:
Zachery Miller
Compliance Officer
U.S. Food and Drug Administration
Zachery L. Miller, PharmD, BCSCP, is a Compliance Officer at FDA CDER’s OCQC (2019-present), ensuring drug safety. He led Regulatory Meetings overseeing 10,000+ drug lots, issued five Warning Letters to non-compliant compounding pharmacies, and co-authored FDA sterility assurance courses. As a drug investigator (2010-2019), he conducted 102 inspections, 19 compounding-focused.
Panelists:
Meghan Murphy
Senior Advisor, Director for Research Strategy and Engagement Compounding Quality COE
FDA
Meghan Murphy is currently a Senior Advisor in the Office of Compounding Quality and Compliance, part of the Office of Compliance within FDA’s Center for Drug Evaluation and Research. She is the Director for Research, Strategy, and Engagement for the Compounding Quality Center of Excellence (COE). She leads and is responsible for day to day operations of the research and analysis, annual conference, strategic planning, and outreach efforts for the COE. She previously served as the Acting Associate Director for Risk Science, Intelligence, and Prioritization for the Office of Unapproved Drugs and Labeling Compliance, Center for Drug Evaluation and Research, in the U.S. Food and Drug Administration. Prior to that, Ms. Murphy was a Pharmacologist in the same organization and worked on addressing scientific and regulatory issues concerning marketed unapproved drugs and drugs compounded by pharmacists. She began her career at FDA as a member of the Department of Health and Human Services Emerging Leaders Program. Ms. Murphy obtained a Ph.D. in Pharmacology and an M.A. in Organic Chemistry from the University of North Carolina at Chapel Hill, and a B.S. in Biochemistry from the University of Maryland, Baltimore County.
Anthony Widenor
Public Health Analyst
Food and Drug Administration
Tony Widenor serves as a Public Health Analyst in the Division of Compounding Policy and Outreach, where he organizes outreach and engagement activities with compounding stakeholders and internal FDA partners. He also co-leads the Compounding Quality Center of Excellence annual conference. Prior to joining FDA, Tony was the lead electronic health record analyst for inpatient and outpatient pharmacy at UChicago Medicine. Before that, he was a quality assurance specialist and implementation project manager at the electronic health record vendor Epic, where he worked on the inpatient pharmacy module. Tony holds a Master of Public Health degree from Johns Hopkins University and a bachelor’s degree from the University of Alabama.