Seminar 04-05 December 2017 «Good Laboratory Practice for microbiological laboratories. Validation of microbiological methods of medicines quality control. Microbiological monitoring in the medicines manufacture. The main aspects of purification in the light of modern requirements for applicable detergents and disinfectants»
Federal State Institution «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation conducts the Educational Seminar «Good Laboratory Practice for microbiological laboratories. Validation of microbiological methods of medicines quality control. Microbiological monitoring in the medicines manufacture. The main aspects of purification in the light of modern requirements for applicable detergents and disinfectants».
The seminar will highlight the current issues of Good Laboratory Practice for microbiological laboratories (requirements for personnel, facilities, equipment, nutrient media/reagents, test cultures, documentation).
Questions of microbiological methods of quality control of medicines validation will be considered.
Recommendations to determine the validation characteristics and acceptance criteria, the scope of verification and validation of pharmacopoeial and non-pharmacopoeial test methods, the development of a validation documents package (plan, protocols, report) will be provided.
During the seminar, the principles of the risk-oriented approach to the development of the Program and the organization of microbiological monitoring of production environment will be considered. Students will gain practical skills in the appliance of risk assessment tools. The main aspects of purification will be presented in the light of current requirements for the applicable detergents and disinfectants.
Upon the completion of the Seminar students will receive participation certificates.
The seminar will be conducted by Asya Anatolyevna Chernyavskaya, Executive Director of the testing & examination center «Microbiolog».
Venue: to be confirmed
Contact person: Ekaterina Ryzhikova
Phone: +7 (915) 455-65-78
- Leading world regulatory agencies discussed the future of remote GMP inspections at ISPE Global Pharmaceutical Regulatory Summit
- Competition announcement for the best symbol of the GxP Academy
- The National scientific center for pharmaceutical evaluation and projects expertise was established on the basis of FSI “SID&GP”
- The Eurasian Academy of Good Practices will host the first GxP-Fest
- The Opening of the GxP Academy unites regulators from the EAEU countries.