Introduction
Inge van Gasteren started her career in 1992 in the Pharmaceutical Industry. Growing from a CRA via the roles of Project Manager, Process Improvement Manager and Line Manager she developed to an independent service provider for the pharmaceutical-, biotechnology- and medical device industry as well as to the related Contract Research Organizations (CROs).
During the last 11 years Inge has developed various Quality Management Systems for start-up biotech companies as well as for Dutch hospitals in line with ICH GCP, ISO 14155, international and national applicable laws
Inge is an enthusiastic dedicated consultant and provides a practical approach for implementing / improving Quality Management Systems, acting as Head QA and conducting CRO/vendor audits and internal audits on behalf of clients.
In addition to the above, Inge also likes to share her clinical research experience by providing training (GCP, local SOPs) and coaching CRAs, Project Managers, QA managers.