Data integrity and computer validation in the analytical laboratory - Webinar von Gesellschaft Deutscher Chemiker e.V. (GDCh)

The main focus of the course is:- Definitions and delimitation of terms- Electronic documentation- V-Modell: With plan and report achieving the desiredsystem- Risk management (ICH Q9) and risk assessment usingthe example of FMEA- Classification of systems- Change management and requalification- Quality assurance in the validation process- Spreadsheet programs- Auditing of computerized systems- IT infrastructure and qualification according to EU GMPAnnex 15"

The aim of the course is for the participants to acquire thecompetence to evaluate computerized systems with regardto their criticality and data integrity in a regulated analyticallaboratory environment and to carry out validations of simplesystems. For this purpose, the participants acquire knowledgeof national and international specifications from thequality systems of GLP, GDP and GMP relevant for researchand development as well as production.