is Partner with GxP-CC, has been at the forefront of quality and compliance consulting with a focus on digital compliance and on data integrity initiatives in the previous eight years.
He has supported many organisations in the pharmaceutical, biotech and medical device sector, executing data integrity campaigns and training initiatives. Ulrich Koellisch has experience in preparing and conducting audits in the GMP and GCP area, supporting both sides, auditors and auditees.
Ulrich Koellischserves as a speaker, panelist and on conference committees (e.g., PDA and DIA) to support leading the pharmaceutical industry towards implementation of modern quality concepts and tools. He aims to bring forward the application of data analytics and quality intelligence by implementing e.g., AI/ML models and dashboarding in a regulatory environment. He presides over the PDA special interest group on data integrity and has trained international regulators on data integrity and quality management concepts.
Ulrich Koellisch holds a M.Sc. in Physics, a Ph.D. in Medical Imaging at the Technical University of Munich and is a fully educated and accredited teacher.