Lead consultant assisting an Asia based pharmaceutical client through their first U.S. FDA Pre-approval Inspection (PAI) and Bioresearch Monitoring (BIMO) inspections. Alia worked closely with the client as well as their CRO, biostatistics vendor, and investigator sites in multiple countries to provide training regarding the U.S. FDA inspection process. Alia also assisted with the development of a quality and risk management plan from both compliance and business perspectives in order to efficiently identify deficient practices and areas for improvement in clinical trials. U.S. FDA reported only minor findings during the inspections.
Expert consultant assisting a leading California compounding pharmacy prepare for and respond to U.S. FDA inspection findings. Alia conducted a gap analysis, several on-site audits, and assisted with drafting responses to FDA 483s observations to avoid agency official action (i.e. Warning Letter). As preventive action to deter future violative conditions, Alia prepared a training program highlighting the Compounding Quality Act requirements and assisted in the revising written procedures to adhere to regulatory requirements and address common deficiencies (e.g. personal protective equipment, environmental monitoring, cleaning and disinfecting, aseptic preparation, testing method procedures) observed during FDA inspections.
Primary consultant supporting a Turkish investigator site during a remote U.S. FDA BIMO Inspection. Alia conducted inspection readiness training with the investigator site personnel prior to the inspection. During the inspection, Alia supported the facilitation of the remote inspection by prepping the site personnel for interviews, tracking Investigator requests, and logistical management of the inspection process at the site. There was no FDA 483 Inspection Observations form issued at the conclusion of the inspection.
