Projektmanagement, Quality Assurance und Quality Control in der klinischen Forschung

Über 25 Jahre Erfahrung in der klinischen Forschung. Tätigkeiten:
• GxP Audits
• CAPA Management
• Monitoring inklusive Site Assessment, Studieninitiierung und Close-out
• Erstellen wesentlicher Studiendokumente
• Prüfertraining - Studie und GCP

• Drug Discovery
• F&E Management
• Fehlermöglichkeits- und -einflussanalyse (FMEA)
• Gute Klinische Praxis
• Gute Laborpraxis (GLP)
• GXP
• Klinische Arbeiten
• Klinische Forschung
• Softwaredokumentation

I understand the complex nature of the clinical research industry and the challenges of maintaining an adequate Quality Management System that ensures data integrity and subjects safety to obtain marketing authorisation and I am passionate to provide guidance and consultancy regarding quality aspects related to QMS, clinical activities and clinical trials.
My mission is to deliver a better clinical experience and clients' confidence in their projects.
During the last 16 years as QA Manager at a CRO offering full-service, including manufacturing processes for IMP, I was able to gain profound knowledge in almost all clinical trial processes. As Head Quality Control GMP I gained a deep understanding for EU GMP Guidelines.
Some of my noteworthy accomplishments include:
• creation and maintenance of a Quality Management System
• successful leadership in obtaining ISO 9001 an 13485 certifications
• establishing a risk management process (FMEA) to comply with ICH GCP E6(R2)
• well overcoming more than 120 sponsor audits and several inspections by CAs

MS Office, GCP, GMP. GLP, ISO 14155, ISO 9001, ISO 13485