Overview of Good Clinical Practice (GCP)

About the Creator

Dr. Alia Legaux is a former U.S. FDA Investigator with more than 24 years of experience monitoring, inspecting and/or auditing of FDA regulated entities, such as Clinical Research Investigator Sites, Clinical Research Organizations (“CROs”), Sponsors, Ethics Committees, Vendors (i.e. safety reporting, laboratory testing, data management, biostatistics, programming, electronic data capture, interactive voice response services, electronic clinical outcome assessments, central reading and imaging), Compounding Pharmacies, Blood Banks, and/or Tissue Banks.   As an Independent Consultant, Alia provides expertise in quality assurance and compliance. She conducts domestic and international routine, directed (for-cause), qualification, re-qualification, and inspection readiness audits, as well as mock inspections of investigator sites, CROs, Sponsors, vendors, compounding pharmacies, drug manufacturers, packagers, or labelers to assess compliance with applicable regulations, protocols, investigational plans, Standards Operating Procedures (“SOPs”), International Conference on Harmonization (“ICH”) Good Clinical Practice (“GCP”), Good Manufacturing Practice (“GMP”), Good Laboratory Practice (“GLP”), Good Clinical Laboratory Practice (“GcLP”), and Good Pharmacovigilance Practice (“GVP”).   Alia shares her knowledge in the varied training courses offered by CRSC.