is the founder of umk consulting GmbH and has been at the forefront of quality and compliance consulting for more than [number] years, with a focus on digital compliance and data integrity initiatives.
In this role, he has supported numerous companies in the pharmaceutical, biotech, and medical technology industries in implementing data integrity campaigns and training initiatives, and has designed concepts for the development and evaluation of validation strategies for AI/ML-based systems. In addition, Mr. Koellisch has extensive experience in preparing for and conducting GMP and GCP audits, supporting both auditors and auditees in this process.
In addition to his consulting work, Ulrich Koellisch serves as a speaker, panelist, and member of conference committees
Translated with DeepL.com (free version) (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.