Jacques Mourrain

Biography

                 "Jacques has developed a pharmaceutical freeze-drying control system application program more than 20 years ago, and has since started his biopharmaceutical career. He has served as an independent certifier for a short time and then joined Fulu Daniel as the director of the validation department, which is responsible for the verification of a number of biopharmaceutical facilities projects, including qualified equipment for cleaning equipment, process equipment, process automation and enterprise information systems. After 2000, Jacques joined Genentech as the head of the Software Quality Assurance Group of the Medical Department. In 2002, Dr. Mourrain founded GxP Computer Systems Compliance at Genentech, which is responsible for information technology compliance throughout the standardized environment. Dr. Mourrain also led a number of initiatives including 21CFR Part 11 and Oliver Wight Class A process optimization. Jacques has extensive knowledge of best practices, validation principles and quality systems for software development under the regulatory environment of the US Food and Drug Administration / US Environmental Management Association. He is a prestigious leader in computer systems compliance, validation and auditing. He has lectured at numerous meetings organized by the American Society for Drug Information, the International Pharmaceutical Engineering Association and the American Injection Association, and has published numerous papers on topics such as compliance audits, change control, quality costs, and computer system validation."  

Research Interest

Pharmaceutical Engineering