Loes Kalkman - Rescop Principal Consultant is speaking at the GMP & GDP in three daysDescription: Loes Kalkman - Determination of risks within Computerized System Validation.
The management of risks is an essential part of Computerized System Validation. This seems to be easy, but it turns out that a lot of risks are not considered which can jeopardize patient safety, product quality and quality of data. The following topics will be discussed:
· Organizational structure (QMS);
· Validation procedures (initial risk assessment with different types (technical/compliance);
· Methodology for applying risk assessment (FRA, FMEA);
· Project Management;
· 3 P's (risks): Process risks, Product risks, Project risks;
· Experience and validation knowledge of employees involved in validation activities.
For more information on the ‘GMP & GDP Driedaagse 2018’ visit www.gmp-driedaagse.nl/. Please note that the language used during this event is Dutch.
Golden Tulip hotel het Ampt van Nijkerk, Berencamperweg 4, 3861 MC Nijkerk