Seminar Nr. 16761
|Non-ECA Members:||EUR 890,--|
|ECA Members:||EUR 790,--|
|EU GMP Inspectorates:||EUR 445,--|
|APIC Members (does not include ECA membership):||EUR 840,--|
Alle Preise zzgl. MwSt.
Tel.: 06221 / 84 44 0 E-Mail: firstname.lastname@example.org
The current GMP regulations and guidelines (ICH Q9, GAMP®5, draft EU GMP Guide Annex 11 „Computerised Systems“) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how its principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing this task.
This Education Course is directed at employees from Production, Quality Control / Quality Assurance, Engineering, IT who have to deal with risk assessment and risk management in the field of computer validation.
Introduction – What do you want from this day?
An Introduction to Risk Management (including ICH Q9)
Risk Management the GAMP® 5 Way
An Introduction to Risk Ranking
Assessing and Selecting a Supplier
Workshop 1: Risk Assessment in Validation
In this workshop, delegates will use the GAMP methodology. The participants will work on a case study in which the risks associated with a computer system are assessed and managed to reduce the testing workload in validation.
Workshop 2: Risk Management in Validation
Based on a real case study, delegates will use the same risk assessment techniques to determine where to focus the qualification of a packaging line
Workshop 3: Applying Risk Ranking to determine periodic review priorities
Delegates will apply the techniques of risk ranking to determine which systems present the highest risk to the patient and should therefore be reviewed first.
Workshop 4: Assessing and Selecting a supplier
Delegates will assess supplier selection information to choose between two possible suppliers for an application.