Dr. Marc Brooks
Trainer
After obtaining his PhD in Biochemistry at the University of Tuebingen (Germany), Dr. Brooks worked for a consulting company in the mobile phone industry as database and middleware administrator. He also had the role as project quality manager during this time and in 2003 he moved on into the pharmaceutical industry as validation manager. He was responsible for the compliance of all computerized systems globally used in clinical development. He has been working for a syringe manufacturing company and a start-up developing a fraud protection solution. In 2008, he started as a consultant in computer systems validation, focusing on clinical development but also working in the preclinical and manufacturing area. Since 2011 he also performs vendor qualification and study audits with focus on GCP and IT, e.g. data management, biostatistics, eTMF, e-archiving.
Reasons to attend Computer System Validation (CSV) in the past often has been anticipated as an obs...