Krishnakali Ghosh PhD VERITAS COMPLIANCE LLC

Krishna Ghosh, Ph.D., is a Medicinal Chemist with over 20 years of industry experience in Product Development, manufacturing, operations, business management, Quality Assurance, Quality Control, and Regulatory Affairs in biotech and pharmaceutical companies. She spent over 15 years with the FDA, working in the device and drug review divisions of CDRH and CDER. She was the subject matter expert for 21 CFR Part 11, Part 4, 211, 210, and 212. Since April 2025, she has taken on a role as an independent regulatory consultant, advising the Biotech and pharmaceutical industries on various strategic, risk, and operational plans for digital transformation, including the integration of Artificial Intelligence to increase efficiency. She was the chairperson for the FDA cross-center initiative, involving CDRH, CBER, CVM, and ORA, on “Cloud Computing.” She developed internal policies governing outsourced IT services and cloud computing usage for regulated products in the pharmaceutical industry. She has extensively worked on NDA and ANDA application reviews of complex drugs since 2012, with a focus on sterile injections, aseptic, and combination drug manufacturing processes. She has conducted manufacturing facility pre-approval inspections in Europe, the US, India, and Japan, and trained various ORA and CDER reviewers in different dosage form inspections.