Ulrich Schmitz

Development of master audit plans; planning, conducting and co-ordinating investigator site audits, TMF-audits, CSR-audits, Pharmacovigilance system audits and vendor audits (CROs); inspection readiness; creation of SOPs related to clinical quality assurance; review of internal SOPs; collaboration with QA service providers; CAPA management, regulatory trainings for employees

Hosting client audits; conducting internal and external audits including reporting according to ICH-GCP; follow-up on corrective actions; creation and review of global SOPs; administration of the EDMS; training of employees (ICH-GCP, 21 CFR Part 11, CAPA system, EDMS); acting as a resource in regulatory and quality related questions

Hosting client audits; conducting internal and external audits including reporting according to international regulations (ICH-GCP, 21 CFR Part 11, ISO 15189 and CAP); monitoring the 21 CFR Part 11 project plan; follow-up on corrective actions, creation and review of local and global SOPs; Training of employees (QA system, GCP, 21 CFR Part 11); review of validation documentation (methods and systems), acting as a resource in regulatory and quality related questions

Establishment of a network for co-investigators in clinical trials; creation of study related material and providing support for co-investigators; patient recruitment

Quality Management according to DIN EN ISO 15189 (Medical Labs); supporting lab manager in all questions regarding quality control (QC) and implementation of QC procedures; method improvement and method validation; creation of standard operating procedures; consulting lab staff on policies and procedures; organizing regular quality meetings

Genotypic HIV-1 resistance testing including result reporting, method validation and proficiency testing (external QC); DNA sequence analysis including development and implementation of new test assays (Human Genetics); routine assay processing (PCR)

Cell and Molecular Biology / Human Genetics