Krishnakali Ghosh, PhD U.S. FDA

Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She currently is the subject matter expert at FDA for 21 CFR Part 11, Part 4, 211, 210 and 212. She has in-depth knowledge in implementation of digital technologies in pharmaceutical manufacturing and has presented at various conferences on proposed challenges and mitigations in adopting the latest digital technologies in a regulated environment. She was the chairperson and lead for FDA cross center initiative from CDRH, CBER,CVM,ORA on “Cloud Computing” to develop various internal policies related to outsourced IT services and cloud computing usage for regulated products for drug manufacturing. 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 process. She has conducted manufacturing facility pre approval inspections in Europe, US, India and Japan as a subject matter expert and trained various ORA and CDER reviewers in various dosage form inspections.