Dr. Nico Erdmann is a Senior Manager in our Life Science / Healthcare Regulatory & Compliance team at Deloitte Regulatory Risk. He has more than 8 years of consulting and working experience in the Life Sciences industry. His focus area is IT Quality in Pharma and MedTech.
He leads the Computerized System Validation (CSV & CSA), Data Integrity and Cloud Compliance activities within Deloitte Germany, and thereby implemented and validated various IT systems in regulated environments, assessed and defined agile and standard validation approaches as well as IT QMS systems. Furthermore, he is a known expert in AI validation. With his depth knowledge of GxP process, he evolved also as an expert in supporting clients with AI and GenAI GxP use cases as well AI GxP validation and implementation strategies.
With the AI Act coming up he is the AI Act ambassador for the LSHC community.