Ulrich Koellisch GxP-CC

Dr. Ulrich Koellisch, Partner with GxP-CC, has been on the forefront of quality and compliance consulting focussing on digital compliance and data integrity in his previous ten 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 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 in a regulatory environment. Ulrich precedes the PDA IG Data Governance, Management, Integrity, and Digitalization and has trained international regulators on data integrity and quality management concepts. 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.