The Educational Center for Good Practices is a structural unit of the FBI “State Institute of Drugs and Good Practices”, it has a license for educational activities issued by the Moscow City Department of Education on December 16, 2015. The license gives the right to conduct educational activities for the implementation of educational programs of the CPE: skills development and retraining of personnel.
The goal of the center is to form an industry-specific system for skills development of the personnel of pharmaceutical production in the Russian Federation.
Objectives: to organize and conduct educational activities to train the personnel of pharmaceutical production, to ensure the quality of training in accordance with professional standards, to develop training programs for various categories of personnel in pharmaceutical enterprises.
- for each good practice, a department and an R&D laboratory were created;
- the results of which are translated into the educational process of the corresponding department;
- methodological department carries out a comparative analysis of the presented curriculum for compliance with the requirements of the professional standard;
- methodological department checks the presented curriculum for the possibility of mastering the skills and abilities stated in the program, as well as improving the existing and acquiring new competencies.
Our training programs are aimed at training specialists in the field of: quality assurance and control, production, warehouses, registration, engineering, specialists who conduct qualification of equipment and engineering systems, process validation.
Currently, the following CPE programs have been developed and approved:
- Additional professional development program for specialists in the production of medicinal products
- CPE Program “Rules and requirements of the Good Manufacturing, Distribution and Engineering Practices”
- Regulatory Practice program
- CPE Program “Planning and conducting preclinical and clinical trials of medicinal products for medical use”
- CPE program “Rules and requirements of good manufacturing practice for the quality control department (QC)”
- CPE Program “Analytical methods of pharmacopeial analysis”
- CPE Program “Training of specialists in certification and declaration of medicinal products”
Each program consists of modules and topics for which training is provided.
The educational center has developed programs for the EEA member states:
- Additional professional development program for specialists of the member states of the Eurasian Economic Union in the inspection (audit) of organizations distributing medicinal products.
Theoretical part – 40 hours, practical part – 132 hours, total – 172 ac. hours
- Additional professional development program for specialists of the member states of the Eurasian Economic Union in the inspection (audit) of enterprises producing medicinal products.
Theoretical part – 40 hours, practical part – 128 hours, total– 168 ac. hours
- Additional professional retraining of specialists of the member states of the Eurasian Economic Union in the inspection (audit) of enterprises producing medicinal products.
Theoretical course – 154 hours, practical course – 126 hours, total – 280 ac. hours
Training is conducted in the following good practices:
- Good Laboratory Practice,
- Good Clinical Practice,
- Good Manufacturing Practice,
- Good Engineering Practice,
- Good Distribution Practice,
- Good Regulatory Practice,
- Good Pharmacy Practice.
According to information from the factories, we have drawn up programs for workshops for individuals and targeted workshops for specific plants. We are looking for the best ways to train specialists. Therefore, along with the traditional form of workshops, we have begun to actively use webinars. We have prepared a special subjects for conducting webinars.
Currently, the Education Center has formed a pool of 26 teachers. Doctors and Candidates of Sciences and Specialists engaged in production at the level of top managers are invited as teachers. Training workshops are conducted.
The number of trainees who attended the workshops and webinars of the Educational Center of the FBI SID and GP in 2016 is 856 people.
During 2016, 45 training events (workshops, webinars) have been conducted.
Our educational activities involved employees of pharmaceutical companies, such as: FSUE NPO Microgen, PJSC Valenta Farm, JSC Akrihin, GEROPHARM LLC, Veropharm JSC and others.