Open Consultative Seminar “Validation of Computerized Systems: Problems and Solutions”
On June 21-22, an open consultation seminar “Validation of Computerized Systems: Problems and Solutions” will take place in Moscow, where Sergey Orlov, Specialist of the Department of Good Engineering Practices of the FSI “SID & GP” will take part.
Today in Russia the validation of computerized systems is an area of many unsolved practical issues. The specificity of the current stage of technological development is that computerized systems are increasingly becoming a critical factor in the effectiveness of pharmaceutical production and the quality of medicines. The lack of guidelines adapted to the technologies used to validate computerized systems seriously complicates the task of meeting the requirements of GMP.
To the extent that IT services become part of the quality assurance system, there is a need to organize their effective interaction with quality assurance services and other elements of this system. The series of seminars “Validating Computerized Systems: Problems and Solutions” is aimed for managers and employees of quality assurance services and IT services, with an emphasis on their interaction. The seminars have a high practical focus and are aimed at mastering GMP standards by participants, working out actual production situations, analyzing problems arising in connection with the validation of computerized systems, and searching for effective solutions.
- Director of “SID&GP” has introduced the statistics of identified non-conformities in the registration dossier
- SID&GP Director took part in the meeting dedicated to pharmaceutical manufacturing localization in the Ryazan region
- Russian GMP-Inspectorate. Summary of “Pharma-2020”
- SID & GP took part in a Conference in honor of the EMA’s 25th Anniversary
- Industry solidarity in training of pharmaceutical personnel