30 October 2019 - Validation of Computerized Systems in GCP Environment

Webinar Topic

Validation of Computerized Systems in GCP Environment



Webinar Date & Time

30 October 2019 from 10:00 AM to 11:30 AM (CEST)


Webinar Overview

Nowadays, the collection, analysis and processing of data originated from a clinical study or for marketing settings is supported by specialized applications. As requested by ICH GCP it has to be ensured and documented that electronic data processing systems conform to “established requirements for completeness, accuracy, reliability, and consistent intended performance.” Therefore, validation of computerized systems has become a central aspect in CRO’s daily work and the validation effort should not be underestimated. With the recent update of ICH E6 (R2) this requirement has been extended to include the concept of “risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.” In addition, the validation of computerized systems is increasingly being addressed in audits and inspections. This webinar aims to give a general overview of validation procedures focusing on validation processes of non-configured (GAMP category 3) and configured (GAMP category 4) products. To illustrate this, we will play through the validation steps with the help of an example. Furthermore, we will present relevant guidelines and typical roles and responsibilities in validation and we will look at what we have learned so far from audits and inspections.





Simone Bucerius

Simone Bucerius (M.Sc. Biology) is Quality Assurance Manager at FGK Clinical Research GmbH. Her experience includes coordination and conduct of GCP and GVP audits, maintenance and further development of the company-internal SOP and training system as well as support in validation of computerized systems.
Previously she worked in the field of Research and Development focusing on DNA sequencing techniques.

Guenter Woelfl

Guenter Woelfl (M.Sc. Physics) is e-Solution Manager at FGK Clinical Research GmbH. His experience includes Selection, Validation and Maintenance of computerized systems for the use in the field of clinical research. Furthermore, he is responsible for user management and training.

Previously he worked more than 10 years as clinical project manager.






Attendance Fee

€ 90,- for non-EUCROF members

€ 60,- for EUCROF members


Deadline for registration

29 October 2019


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