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.
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)