Thomas J. Arista

Mr. Arista is currently a Field Investigator at National Expert Pharmaceutical & Biotechnology with the FDA’s Office of Regulatory Affair’s Office of Pharmaceutical Operations. Mr. Arista is one of ORA’s National Expert Investigators in pharmaceuticals and for the past 30+ years has accumulated a global appreciation and technical expertise with respect to pharmaceutical manufacturing and Quality Control tests. 

Mr. Arista has been with the FDA for a number of decades and most recently was the previous Deputy Director of the FDA’s Office in New Delhi, India. He has worked with a number of international standard organizations that established internationally recognized standards e.g., the American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI), and the Parenteral Drug Association (PDA) committees regarding Microbiology. 

Arista has worked with recognized health authorities from around the world that include, for example, the WHO’s International Consultation of Experts to Review the WHO Programme Policy, Process, and Indicators for Strengthening NRAs Regulating Health Products and Technologies; the Pharmaceutical Inspection Convention / Scheme (PIC/S) regarding regulatory global compliance, and as the Co-rapporteur of PIC/S Joint Assessment and Inspection (2015) of COFEPRIS (Mexico - Comisión Federal para la Protección contra Riesgos Sanitarios/ Federal Commission for the Protection against health risks). 

Mr. Arista has teamed with a number of regulators from around the world e.g., MHRA, EMA, EDQM, WHO, SwissMedic, Santé Canada, Therapeutics Goods Administration (TGA – Australia), China FDA, Japanese Ministry of Health & Welfare, and with the Nigeria National Agency for Food and Drug Administration and Control (NAFDAC).