Are You in Control of Your Data



Computer Validation: Introduction to Risk Management


2014, November 18

Pharmaceutical » Training


You get to know the current risk management approaches of ICH Q9 and the GAMP®5 
You become familiar with the latest methods and tools for risk analysis and can assess their relevance to practice in the validation of computerised systems
You learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management
In 4 workshops you can apply the procedures and discuss them 

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. 


Venue

Corinthia Hotel Prague
Kongresova 1
Prague,
14069
Czech Republic

Organizer

Concept Heidelberg
Phone: +[49] 62 21/84 44 0
Email: info@concept-heidelberg.de
Visit organizer website



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