Fortbildung

Datum VA-NR Veranstaltung  
11.06.2021 530/21

Online-course: Data integrity and computer validation in the analytical laboratory (530/21)

Ort: Online
Referent: Carsten Buschmann
Art: FB

am 11.06.2021


Link:
Anfrage von Informationsmaterial

Kontaktdaten:
fb@gdch.de
Tel.: +49 69 7917-364/-291
Fax: +49 69 7917-475

Ziel:
The aim of the course is for the participants to acquire the competence to evaluate computerized systems with regard to their criticality and data integrity in a regulated analytical laboratory environment and to carry out validations of simple systems. For this purpose, the participants acquire knowledge of national and international specifications from the quality systems of GLP, GDP and GMP relevant for research and development as well as production.

Inhalt:
The main focus of the course is:
■ Definitions and delimitation of terms
■ Electronic documentation
■ V-Modell: With plan and report achieving the desired
system
■ Risk management (ICH Q9) and risk assessment using
the 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 GMP
Annex 15

Zielgruppe:
People from laboratory, IT, quality assurance as well as laboratory manager, head of quality control

Gebühr für Mitglieder: 560 EUR

Gebühr für Nichtmitglieder: 630 EUR

zuletzt geändert am: 06.11.2017 17:35 Uhr