Krishnakali Ghosh

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 is the Chairperson for the FDA cross center “ Cloud Computing workgroup”. Krishna Ghosh has worked as a Compliance and Regulatory Reviewer on several high profile compliance/enforcement cases including injunctions, seizures and civil money penalties. She was also involved in various post-market application reviews associated with device changes including PMA software. Krishna has worked closely with firms and regulatory bodies like AAMI and BSI to develop novel regulatory approaches for web based applications, cyber security and cloud computing. Her involvement with inspections, high-risk class 1 recalls, and post market clinical studies have helped to remove approved devices from the market in 2011. She has extensive knowledge of GMP, GLP, GCP and Quality Systems Regulations, program and project management techniques. She has conducted manufacturing facility audits in Europe, US and Japan and has established FDA compliant manufacturing facilities in Europe and US for API's, biologics and devices. She served as an advisory member at FDA and NIST from 2001-2003 for Gene Expression Technologies. Krishna was awarded the "AWIS Professional Award" in 2003 for her outstanding work in mentoring scientists and students to transition from academics to industry. She has presented at several conferences on the latest developments in regulatory initiatives and guidelines at FDA. She was nominated as a "Distinguished Executive VP of Operations" in 2006 Cambridge's Who's Who Directory during her tenure with Genemed Biotechnologies Inc. Krishna assisted several Bay Area Biotech/ Diagnostics/ Pharmaceutical startup companies to build an effective and robust quality & regulatory infrastructure with FDA compliant policies and regulations.