Monica Koenig
Cadence Quality Assurance LLC
President
Monica Koenig (formerly Caphart) is an experienced former regulator with +30 years of experience at the US Food & Drug Administration (FDA). Her FDA work experience includes positions with responsibilities in strategic and organizational planning, senior-staff supervision, regulatory program leadership, training and education in support of programs to protect public health. Her FDA career includes positions in FDA’s regulatory laboratories, CDER’s Office of Compliance, Division of Manufacturing and Product Quality (technical/regulatory specialist on pharmaceutical laboratory cGMPs), and ORA’s Division of Field Investigations, Office of Medical Products and Tobacco Operations and Office of Training Education and Development.
Monica is a Mansfield Fellow whose fellowship included working in the GMP Section at Japan’s Ministry of Health, Labor and Welfare. During this fellowship, she also completed internships in the office of a Japanese Diet member and at a Japanese Pharmaceutical Company. Her international experience also includes serving as an FDA/ORA representative to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and member of the PIC/S Sub-Committee on Training and Sub-Committee on Strategic Development; CDER/OC representative to the International Council for Harmonisation (ICH) Quality Expert Working Groups for Q7, Q10 and Q11; and secondment as Visiting Expert to the European Medicines Agency (EMA) to strengthen regulatory cooperation between the US FDA and the EU. In addition, she provided oversight for the CDRH Medical Device Single Audit Team during initial planning and completion of early deliverables associated with the Medical Device Single Audit Program (MDSAP).
Monica currently serves as a lecturer in Purdue University’s Department of Agricultural and Biological Engineering, Biotechnology Innovation and Regulatory Science Center Master of Science and Global Certificate programs in West Lafayette, IN and volunteers as a lecturer with these Purdue programs in Tanzania. She holds a bachelor’s degree in Chemistry and master’s degrees in Pharmacology and Public Health.
Monica is a Mansfield Fellow whose fellowship included working in the GMP Section at Japan’s Ministry of Health, Labor and Welfare. During this fellowship, she also completed internships in the office of a Japanese Diet member and at a Japanese Pharmaceutical Company. Her international experience also includes serving as an FDA/ORA representative to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and member of the PIC/S Sub-Committee on Training and Sub-Committee on Strategic Development; CDER/OC representative to the International Council for Harmonisation (ICH) Quality Expert Working Groups for Q7, Q10 and Q11; and secondment as Visiting Expert to the European Medicines Agency (EMA) to strengthen regulatory cooperation between the US FDA and the EU. In addition, she provided oversight for the CDRH Medical Device Single Audit Team during initial planning and completion of early deliverables associated with the Medical Device Single Audit Program (MDSAP).
Monica currently serves as a lecturer in Purdue University’s Department of Agricultural and Biological Engineering, Biotechnology Innovation and Regulatory Science Center Master of Science and Global Certificate programs in West Lafayette, IN and volunteers as a lecturer with these Purdue programs in Tanzania. She holds a bachelor’s degree in Chemistry and master’s degrees in Pharmacology and Public Health.