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GCP QC Services and Computerised System Validation

GCP QC Services and Computerised System Validation in compliance with GCP and GMP

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GCP QC Services and Computerised System Validation | pharmaix.de Reviews
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GCP QC Services and Computerised System Validation in compliance with GCP and GMP
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1 clinical monitoring
2 monitoring
3 audit
4 co-monitoring
5 GCP
6 GMP
7 valididation
8 Computer
9 Network
10 infrastrukture
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computerised system validation,gcp qc services,imprint/ disclaimer,andreas kühnel,network qualification,business continuity mangement,andrea plum,sponsor oversight programs
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GCP QC Services and Computerised System Validation | pharmaix.de Reviews

https://pharmaix.de

GCP QC Services and Computerised System Validation in compliance with GCP and GMP

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1

Computerised System Validation

http://www.pharmaix.de/kuehnel.htm

Validation of computerised systems. Planning and implementation of the essential infrastructure. Writing of SOPs in compliance with GMP and GCP. EU GMP Annex 11. EU GMP Annex 15. 21 CFR Part 11. Civil Engineer, Technical University of Aachen (RWTH Aachen). ITIL Foundation Certificate in IT Service Management. Certified Computerised Systems Validation Representative. IT Project Manager within Life Science Industry for more than 15 years. Infrastructure and Network Qualification. Dipl-Ing. Andras Kühnel.

2

Monitoring and Co-Monitoring of Clinical Trials - Andrea Plum, Aachen

http://www.pharmaix.de/plum.htm

To this homepage providing information about my services to the Pharmaceutical Industry, Manufacturers of Medical Devices and to Contract Research Organizations. I am a clinical monitor with 10 years experience as employee in the pharmaceutical industry followed by 13 years as freelance CRA based in Germany. As an intensification of the above I offer site audit services. As freelance based in the city of Aachen I am working on my own with logistical and IT support for tasks in the office if needed.

3

GCP QC Services and Computerised System Validation

http://www.pharmaix.de/sitemap.htm

Kühnel und Plum GbR. Kühnel und Plum GbR. Regions of Monitoring and Co-Monitoring. Professional and EDC Experience.

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GCP QC Services and Computerised System Validation

Kühnel und Plum GbR. Validation of computerised systems. Planning and implementation of the essential inrastructure. Writing of SOPs in compliance with GMP and GCP. 25 years experience in Clinical Research. Drug and Device Trials. Clinical monitoring in Europe, phase I III for sponsors in Europe and US. On-site monitoring oversight visits in Europe for sponsors in Europe and US. Trial Master File Reviews. Audit and Inspection Readiness Assessments.

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