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Ramakrishna Velicheti, Ph.D.
Program/Validation Manager at CBER, FDA

Profile

Dr. Velicheti is working as a Program/Validation Manager in the Division of Biological Standards and Quality Control, CBER. He received a Ph.D. from Osmania University, India, specializing in microbial ecology and analytical chemistry. Dr. Velicheti worked as a Post-doctoral Research Associate at the University of Illinois at Urbana-Champaign, IL, University of Minnesota at Saint Paul, MN, and Oregon State University, OR. before joining pharmaceutical industry, where he worked both in manufacturing and testing of new and generic drugs, biotech and biologics for about 10 years. His experience includes technology transfers and consultant to industry on technologies and method validations.  He worked at BioReliance Corporation for 6 years as Director of Validation, where he supervised method validations prior to joining the FDA in 2006. Dr. Velicheti contributed as a co-author of the FDA Bioanalytical Method Validation Guidance for Industry.  His current responsibilities include methods and equipment validation, process improvement, and he also serves as a Contracting Officer Representative.

Agenda Sessions

  • KEYNOTE: Considerations for Method Validation with Reference to ICH Guidance

    9:35am
  • Live Q&A with FDA

    10:50am