Dieter Weiss

Einführung von neuen globalen Computersystemen in GxP-Umfeld insbesondere in der Laborumgebung. Herausarbeiten von neuen Prozessen zur GMP- und Data Integrity -konformen Erzeugung, Verwaltung, Langzeitsicherung und Archivierung von elektronischen Daten.

* Responsible for Data Integrity * Validated the status of established analytical method validations according to external and internal regulations (ICH, FDA Guidelines, Pharmacopoeia, SOPs) * Qualified analytical instruments acc. to external and internal regulations * wrote and reviewed SOPs for operation and verified analytical instruments periodically * Validated spreadsheets (MS Excel) used for calculation of assay, degradation and other results obtained in the labs