Krishna Gosh, Ph.D. has over 15 years of experience in Product development, Operation/ Business Management, Quality Assurance and Quality control in Biotech and Pharmaceutical companies. In the past 6 years she has primarily focused her attention in emerging Gene Expression Technologies and the challenges associated these technologies as Diagnostics Devices. Her in-depth knowledge in GMP, GLP, Quality Systems Regulations and Program Management techniques have been earned recognition in the Biotech community. She established a Quality/Regulatory and Program Management department at Agilent Technologies Life Sciences Division and validated two manufacturing facilities along with all the processes to successfully launch Commercial Microarrays as a Gene Expression Technology. She spearheaded two strategic initiatives with FDA and NIST to develop regulatory guidelines for this new technology and develop Scanner Standards for NIST.
She is an advisory member at FDA and NIST and she was awarded the " AWIS Professional Award" in 2003 for her outstanding work in mentoring scientists and students to transition from academics to industry. 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. Dr. Ghosh is assisting Biotech/ Diagnostics/ Pharmaceutical start up companies to build an effective and robust infrastructure for Business / Operational excellence focused towards high throughput Genomics technologies.
Krishna will cover issues that will turn your FDA inspection into a nightmare. These mistakes are very general and are applicable towards all types of inspections. She will highlight these mistakes with a number of real life examples and discuss ways to prepare so that you will avoid these mistakes.
