Francois Coussin

Francois Coussin currently serves as a Senior Consultant for Quality at FC-Qualité SAS, where he leverages over three decades of extensive experience in the pharmaceutical and API chemistry sectors. His role involves providing strategic guidance and hands-on support to pharmaceutical manufacturers and suppliers across the globe, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. Francois specializes in preparing companies for GMP inspections, conducting comprehensive audits of suppliers, subcontractors, analytical laboratories, packaging facilities, and excipient manufacturers. His expertise in quality management encompasses laboratory oversight, microbiological monitoring, raw material control, and the management of QC and QO processes, ensuring that all operations meet stringent quality criteria.

A key aspect of Francois’s work involves troubleshooting complex deviations, investigating root causes, and implementing effective CAPA (Corrective and Preventive Actions) to remediate issues swiftly and sustainably. His deep understanding of data integrity principles, including compliance with 21 CFR Part 11 and other regulatory requirements, allows him to identify vulnerabilities and strengthen laboratory controls. Francois also supports clients in preparing for regulatory inspections, facilitating smooth interactions with authorities such as the EMA and FDA, and ensuring readiness for both routine and surprise audits.

His expertise extends to managing laboratory and quality department operations, optimizing processes, and fostering a culture of continuous improvement. Francois’s comprehensive knowledge of GMP compliance, coupled with his practical experience in trouble-shooting and remediation, makes him a trusted partner for organizations seeking to uphold the highest quality standards in pharmaceutical manufacturing and API development.