Mohsen Eghbal is a Managing Partner with Validant, based in the EMEA region. Mohsen has over 30 years of pharmaceutical and biopharmaceutical experience; some of the most recent projects he managed included assessment and preparation of client’s sites for FDA inspection in Europe and India.

These projects’ scope included preparation of response to FDA  483/warning letter, preparation of manufacturing sites, reengineering of the quality management systems, and comprehensive site readiness for  FDA inspection. These projects required detailed evaluation of the QA and manufacturing activities, full re-engineering of the Quality and Compliance processes, preparation of SOPs, and implementation of critical elements of the quality management system. Mohsen was also responsible for evaluating and validating the manufacturing processes; including protein extraction, freeze-drying, etc. The most recent project that he managed was in a β-Lactam antibiotics manufacturing site. He has managed the qualification of equipment, computerized systems, facilities, and utilities. Additionally, he supported the BLA preparation and reviewed the final packages before submission to the US FDA. Mohsen has been the lead host of the FDA inspection of his client’s sites, and he successfully passed the inspections and subsequently attained approval and launch of a new product into the US market.

Mohsen has a wealth of experience in Data integrity assessment. He had analyzed and reviewed manufacturing batch records and Quality Control data for consistency and accuracy to support data integrity challenges by FDA and MHRA. He has reviewed product development packages, including clinical batch records, for completeness and data accuracy before submitting to the FDA.

Mohsen has developed and implemented sustainable quality and compliance management systems in several international companies. He has a  proven track record of remediating critical manufacturing challenges and preparing sites for recertification by regulatory authorities (FDA). He is also fully conversant with the development and utilization of risk management tools. He has been managed remediation processes for several FDA  Consent Decrees.

Mohsen has in-depth experience in design, qualification, operation, and maintenance of bulk biotech manufacturing equipment, processes and utility systems, and associated quality systems for non-conformances, change controls, and corrective and preventive actions, etc.

Before consulting, Mohsen has worked as the Head of Global Quality Assurance at Sandoz Pharmaceuticals in Germany. He has also held the position of VP of Corporate QA and Compliance at Serono Pharmaceuticals in Switzerland (subsequently Merck KGaA), and VP of Corporate QA and  Compliance at Elan Pharmaceuticals in Ireland. During the late 80s and throughout the 90s, he held positions of increased responsibilities at Alza  Pharmaceuticals, Fisons Pharmaceuticals, Glaxo Inc., and Burroughs Wellcome.