Auditing the QC Microbiology Laboratory for FDA Compliance


This microbiology laboratory training will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures and resolution of audit findings.

Visitors

Training,Consultants,Auditors and Inspectors

Exhibitors

Chitra Edwin, Ph.D., RAC. has significant 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 a key member in the development of products for AIDS and cancer that have obtained regulatory approval. She has successfully established and managed GLP and CLIA compliant laboratories, managed multidisciplinary project teams, executed technology transfers, and orchestrated collaborations between national and international professionals. Dr. Edwin’s responsibilities have included the pre-clinical development of therapeutic biologics, vaccines and diagnostics. She has functioned as a facilitator between academia and industry that culminated in contractual service agreements, and organized professional meetings with representatives from academia and the bioscience industry.

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