Mohsen Eghbal is a Managing Partner with Validant, based in the EMEA region.
Mohsen has over 30 years of Pharmaceutical 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. The scope of these projects included preparation of response to FDA 483/warning letter, preparation of manufacturing sites, reengineering of the quality management systems, plus comprehensive site readiness for FDA inspection. These projects required detail evaluation of the QA and manufacturing activities, full re-engineering of the Quality and Compliance processes, preparation of SOPs, along with implementation of critical elements of the quality management system. Mohsen was also responsible for the evaluation, and validation of 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 qualification of equipment, computerised systems, facilities, and utilities. Additionally, he supported the preparation of the BLA and reviewed the final packages prior to 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 analysed and reviewed manufacturing batch records and Quality Control data for consistency and accuracy in support of data integrity challenges by FDA and MHRA. He has reviewed product development packages including clinical batch records for completeness and data accuracy prior to submission to FDA.
Mohsen has developed and implemented sustainable quality and compliance management systems in several international companies. He has a proven track record remediating critical manufacturing challenges and preparing sites for recertification by regulatory authorities (FDA). He is also fully conversant with the development and utilisation 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, as well as associated quality systems for non-conformances, change controls, and corrective and preventive actions, etc.
Prior to 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.