Loading…
The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

Please review the Safety Rules and Guidelines.
avatar for Dr. Krishna Ghosh

Dr. Krishna Ghosh

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 has extensive experience in establishing GMP manufacturing facilities for API's, biologics and devices as well. She joined FDA in 2010 and held the position as a Senior Policy Advisor and FDA subject matter expert for PET and Radiopharmaceutical drug CGMP, 21 CFR Part 11 and 21 CFR Part 211. She is the chairperson for FDA cross center initiative involving CDER, CDRH, CBER, CVM and ORA for “Cloud Computing” to develop various internal FDA policies related to outsourced IT services and cloud computing usage for regulated products for pharmaceutical manufacturing and testing. She has extensive automation validation expertise including integrated drug manufacturing processes and has been involved in application reviews and inspections of drug products and “continuous manufacturing” applications.  She has conducted facility inspections in Europe, US, India and Japan as a subject matter expert presented at several conferences on the latest developments in regulatory initiatives and guidelines at FDA related to cloud computing, data integrity, Pre approval inspections, PET and radiopharmaceutical drugs and GMP quality system regulations.

My Speakers Sessions

Tuesday, April 10
 

10:30am PDT

Morning Plenary Platinum 5&6Beth Moulaison • Chrissy Cochran • Dr. Krishna Ghosh

 
Wednesday, April 11
 

10:30am PDT

 
Thursday, April 12
 

10:30am PDT