Prior U.S. FDA Consumer Safety Officer/Investigator inspecting BIMO [Phase I, II, III, and IV clinical trials), blood banks (FDA Level II Investigator in Blood Banking/Apheresis), tissue banks, IRBs, medical gas, drug manufacturers, packagers, or labelers and contract facilities/vendors required to adhere to federal regulations and recommendations related to GMP, GCP, GcLP, regulatory documents, donor screening/testing, donor notification, site qualification, ethics committee, protection of human subjects, case report forms, severe adverse event reports, and informed consent. Alia also prepared regulatory documents for distribution within the Agency and/or for public administration, including training materials, written reports of inspectional observations and establishment inspections, and recommendations for regulatory enforcement. Moreover, she evaluated written responses from blood banks, tissue banks, IRBs, Principal Investigators, Sponsors and Vendors regarding corrective actions plans to FDA 483s to determine the adequacy of proposed corrections and preventive actions. As a member of the International Inspection Cadre, Alia served as the Lead Investigator on multiple international inspections.
Expert consultant conducting audits of domestic and international investigator sites, CROs, Sponsors, and vendors to assess compliance with protocol, SOPs, ICH GCP, GcLP, and all applicable regulations; preparing written preliminary summaries and audit reports regarding audit observations; and ensuring the timely and effective follow up of all identified or assigned quality issues, and reviewing TMFs, including a variety of regulatory documents (e.g. FDA 1572s, informed consents, financial disclosures) for accuracy and completion.
Senior Auditor conducting audits of data management, biostatistics, and programming vendors to assess compliance with the protocol, 21 CFR part 11, ICH GCP, good programming standards, study-specific plans, Software Development Life Cycle (SDLC) principles, business continuity/disaster recovery plans, global data privacy/data protection policies, company SOPs, and current industry concepts in computerized system validation.
Quality Assurance Consultant/Senior Auditor conducting audits of domestic and international investigator sites, CROs, Sponsors, and vendors to assess compliance with the protocol, SOPs, ICH GCP, GMP, GLP, GcLP, and all applicable regulations; providing input into QC plans and processes relating to assay validation and environmental monitoring; reviewed SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations; assessing vendor qualification, management, and certification programs; and maintaining open and frequent communications with external and internal stakeholders.
