Thomas J. Arista

Mr. Arista was the previous Deputy Director of FDA’s Office in New Delhi, India (2018-2019). Prior to joining the Office of International Programs’ India FDA Office, Mr. Arista is one of ORA’s National Expert Investigators in pharmaceutical / biotechnology and for the past 30+ years has accumulated a global appreciation and technical expertise with respect to pharmaceutical manufacturing and Quality Control tests. He has worked with a number of standard organizations that establish internationally recognized standards e.g., American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI) ISO-13408 Aseptic Processing of medical health products; ISO – 14644 Cleanrooms and associated controlled environments, and with the Parenteral Drug Association (PDA) committee regarding TR-88 Microbial Data Deviation Investigations in the Pharmaceutical Industry. He 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. Mr. Arista has performed a number of inspections and collaborations with global regulators e.g., MHRA, EMA, EDQM, WHO, SwissMedic, Santé Canada, TGA, China FDA, Japanese Ministry of Health & Welfare and with the Nigeria National Agency for Food and Drug Administration and Control (NAFDAC). And, has collaborated with CDER’s Emerging Technology Team regarding new and innovative technologies for the manufacture of pharmaceutical commodities.

Mr. Arista continues to teach at varied pharmaceutical training courses for FDA Centers, ORA Field Investigators, Compliance Officers and Review Staff and in recent years has been an FDA representative during several FDA India workshops.