Dr. Ulrich Koellisch, Partner with GxP-CC, has been on the forefront of quality and compliance consulting with a focus on digital compliance and for data integrity initiatives in his previous eight years.
He has supported many organizations in the pharmaceutical, biotech and medical device sector executing data integrity campaigns and training initiatives. Ulrich has experience in audit preparation and conduction in the GMP and the GCP area, supporting both sides, auditors and auditees.
Ulrich serves as 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. Ulrich precedes the PDA special interest group on data integrity.
Ulrich combines international regulatory knowledge with hands-on implementation experience for quality, and data integrity / data governance programs. He considers technical aspects to enable those and has a focus on the human factor which is influenced by the companies’ quality culture.
Ulrich holds a M.S. in Physics, a Ph.D. in Medical Imaging at Technical University of Munich and is a fully educated and accredited teacher.