ComplianceOnline

Expert Profile


Chitra Edwin
Principal, Biotechnology Consulting Solutions LTD

Ph.D. has over 15 years of product development and management experience in start-ups, mid-sized and large biotechnology and diagnostic companies. She has managed projects from concept, R&D through manufacturing transfer, and has been involved in the development of commercial products for AIDS and cancer.Dr. Edwin obtained her Ph.D. in Medical Microbiology and Immunology from the University of Minnesota followed by post-doctoral training at the Harvard Medical School and the Dana Farber Cancer Institute. She has obtained Regulatory Affairs board certification (RAC) from the Regulatory Affairs Professional Society. She is an Adjunct Associate Professor of Pharmaceutical Sciences, College of Pharmacy; University of Cincinnati, and the Director of the Capstone project.

Trainings by Expert

Auditing the QC Microbiology Laboratory for FDA Compliance
Category: Laboratory Compliance , Quality and Safety , Audits & Inspections , Laboratory , Microbiology Laboratory , Audit & Inspection-Role , Lab Audit , Life sciences QA/QC , Life Sciences , QA/QC

Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy
Category: Biotechnology , Testing and Validation , Technologies and Processes , Biologics and Biosimilars , Life sciences QA/QC , Life Sciences , QA/QC

Key Trainings to Improve Quality and Safety in Laboratory
Category: