Data integrity and computer validation in the analytical laboratory

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.

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

Target group:

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

» Programmdetails und Anmeldung

• Rechnungswesen, Jahresabschlussanalyse (18. - 19.05.2021 Seminar (online))
• Lebensmittelkennzeichnung leicht gemacht - Die Do's and Dont's der Pflichtkennzeichnung (18. - 19.05.2021 Seminar (online))
• Qualitätsverbesserung und Kostenreduzierung durch statistische Versuchsmethodik (19. - 20.05.2021 Seminar (online))
• Design of Experiments (DoE) Workshop (21.05.2021 Seminar (online))
• Lebensmittel & Recht - was gibt's Neues? (08. - 09.06.2021 Seminar (online))

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