Thomas J. Arista, BA U.S. FDA

Mr. Arista was a previous Deputy Director, FDA’s Office in New Delhi, India (2018-2019). Mr. Arista is one of Office of Regulatory Affairs' National Expert Investigators in pharmaceutical / biotechnology and for the past 30+ years has accumulated a global appreciation & technical expertise with respect to pharmaceutical manufacturing and Quality Control tests. He has worked with a number of international standard organizations 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. He has worked with international health authorities e.g., the WHO’s International Consultation of Experts, the Pharmaceutical Inspection Convention / Scheme (PIC/S) regarding regulatory global compliance. Mr. Arista has teamed with international regulators e.g., MHRA, EMA, EDQM, WHO, SwissMedic, Santé Canada, TGA, China FDA, the NAFDA and with CDER’s Emerging Technology Team (ETT) focused on new and innovative technologies for the manufacture of pharmaceutical commodities.

Mr. Arista continues to teach at pharmaceutical training courses for FDA Centers, Field Investigators, Compliance Officers, Review Staff and FDA representative at FDA India Pharmaceutical workshops. Mr. Arista has a BA in Biology from the University of Texas – Arlington.