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ФАРМАЦЕВТИЧЕСКИЕ НАУКИ
Education and professional training of production staff on the example of the Scientific Centre of Anti-Infectious Drugs Azembayev A.1, Uteev R.2, Adibayeva G.3, Kalykova A.4 Образование и профессиональное обучение производственного
персонала на примере Научного центра противоинфекционных препаратов Азембаев А. А.1, Утеев Р. А.2, Адибаева Г. К.3, Калыкова А. С.4
1Азембаев Амиркан Аканович /Azembayev Amirkan - кандидат фармацевтических наук,
заместитель председателя, АО «Научный центр противоинфекционных препаратов», г. Алматы, Республика Казахстан;
2Утеев Рауан Адаевич / Uteev Rauan - эксперт, Министерство здравоохранения и социального развития Республики Казахстан,
Комитет контроля медицинской и фармацевтической деятельности, Управление оказания фармацевтических услуг, г. Астана, Республика Казахстан;
3Адибаева Гаипжамал Кабдолдановна / Adibayeva Gaipzhamal - преподаватель, фармацевтический факультет;
4Калыкова Асем Сериковна / Kalykova Assem - PhD, преподаватель, главный технолог АО, кафедра фармацевтической технологии, Казахский национальный медицинский университет им. С. Д. Асфендиярова, АО «Научный центр противоинфекционных препаратов», г. Алматы, Республика Казахстан
Abstract: staff's training is the key principle ofprofessional education development. Аннотация: обучение персонала является ключевым принципом развития профессионального образования.
Keywords: competence, training, in-company training, learning process.
Ключевые слова: компетенция, обучение, корпоративное обучение, процесс обучения.
The main requirements in medical treatment is high level qualified personnel that requiring continuously trained specialists due to the introduction of high quality standards, new technology development and drug quality improvement. There exists a process of permanent accumulation of information and experience in the world, therefore always need to update a knowledge. Employee who hasn't updated his knowledge once at 1 -2 years may become incompetent and unclaimed. In order not to fall further behind of progress it is necessary to study systematically and constantly. Present life conditions dictate the necessity to combine work and education with qualification improvement which will be needed for professional, career and personal development. Trainings should not be limited only with new information. It should also include all components which form a person as a specialist in a certain sphere and his perception of world which are prerequisites of practical knowledge use [1].
Integration processes held in pharmaceutical market induces the necessity in harmonization of internal processes with international ones, it is also recommended by the WHO. Therefore there occurred need in improvement of postgraduate training systems, provided with a great flexibility and efficiency in reaction to changes that took place in the area of drug treatment.
The company management has to take actions in improvement of employees' professionalism in order to maintain the company in proper level and to be competitive.
In-company training intends to provide a continued education for specialists and to prepare the staff to solve wide range of tasks. These measures assure continued competence of staff in the process of professional activities.
Changing market require new and original approaches of organizations to create and implement in-company training programs. Such programs can be specially designed it in accordance with the development strategy of the company and its principles in staff management.
There is a difference between professional in-company training and qualification development in postgraduate training system:
- in-company training is considered as systematic process to improve the professional level of staff any company with a view to obtain new professional qualities, knowledge, skills. This training will be formed when specialist is needed for the organization according its development strategy;
- system of postgraduate education is aimed to update the existing theoretical knowledge and skills of specialists in accordance with the requirements of state educational standards and features of the development of industry by approved standard educational program.
Professional training of staff is one of the functions in personnel management which is implemented independently or with training program for staff. It is oriented to eliminate existing deficiency in the knowledge and skills of employees. This is in the interest of the organization to develop competence of staff in all spheres. The training program is the organizational form in education process of staff. The training program has internal structure which includes educational event by category, forms and methods of educational process.
One of the main requirements of GMP is staff's qualification. Each employee must have appropriate education, experience and skills. Effictiveness in manufacture work depends on workers competence, because one of the main resource of company is the staff and its competence. Therefore, it is very important to have sufficient qualified staff to solve the problems that is in the manufacturer's responsibility.
It is believed that D. Mc Clelland, L. and C. Spencer studied the first questions of the competence-based approach in the staff management [2-4].
Competence (from Lat. Competo - Matches) is the ability, skill, knowledge and personal qualities of worker which contribute to obtain high results in professional activities.
In addition to this there is so-called universal competence in literature which discloses leadership, initiative, concentration on results, systematical thinking, responsibility, stress tolerance and ability to work in team in specialist.
List of competencies which ensure efficient implementation of certain position task until employee behavior called competency model (fig. 1).
Fig. 1. Competency model
There are three different types of competence in model of competence: organizational, functional and role.
Organizational competence - spread to all staff in organization regardless of their position.
Functional competence - is requirement in implementation of tasks with skill and obligations prescribed by job regulation of the employee.
Role competence - is requirements to official behavior of employee.
Model of competence can be considered like a basis for further training of pharmacy specialists, independent professional development, formal postgraduate training programs which are aimed to bridge the gap between existing level of employee's development competence and model of competence in position. Such approach helps to enhance motivation and inspiration in staff's labor, for example, determination of salary depending on the achieved level of competence.
Competence's analysis of pharmaceutical positions contributes in implementation of the strategic goals of the organization and to the formation of a transparent system of staff management, in solving tactical problems and to improving standards of work to improve the quality of products.
Competence estimation is determining degree of conformity of worker's professional quality, behavior and results of position by definite standard. Thus, effective implementation of tasks and obligations of specialists are related to existence and development of staff's certain competences.
One of the main strategies for staff in GMP requirements are that these standard rules relies on employees:
- on system developers;
- on employees who use this system;
- on employees who investigate the system in order to check if it works.
Workers of all levels form the basis of the organization and their full involvement enables the organization to use their abilities with benefit and leads to the following actions of employees:
• independence and responsibility in solving problems;
• activity in searching of opportunities to improve the quality;
• creative contribution in realization policy and aims in the field of quality;
• initiative of workers in the expansion of own competence, knowledge and skills;
• improving the company's image in the eyes of the customers and the public;
• enjoy the work in the organization;
• proud to be belonged to the company.
Number of staff should be sufficient to do the work for which the manufacturer is responsible. These people need to have a level of training and experience which allows them to do their work qualitatively. Each employee must clearly understand their individual responsibilities, which should be documented in writing.
Staff that involved in quality assurance should have the power to fulfill their responsibility. Employees in high positions must do certain duties described in the job descriptions, and have the appropriate authority for their implementation. Terms of responsibilities of staff should cover all aspects of GMP.
All employees must read the principles of GMP related to them and must be trained according to standards. Education must cover the needs of staff and correspond with company's policy with regards to human resources.
Selection
and-hiring- -
of-staffn
Initial- c Follow-up- c Formation-of
traming of- training^ personnel -
staffn reserven
Fig. 2. The scheme of staff's training for the formation ofpersonnel reserve
As it can be seen from the scheme, training is divided into «primary», «following», which leads to the formation of personnel reserve.
Education process should not only provide with qualified staff, but also contribute to obtain the motivation to ensure and to support high standards of quality of manufacturer.
In order to provide high quality products management of the company should achieve staff's interest in it. The company's policy for staff must be structured to encourage people, provide elaboration and support with high quality standards in the process of performing any type of work.
Fig. 3. Factors in staff training
One of the factors of training depends on planning training courses for employees according to their duties. Stimulations of training are increasing the competence and skills in the workplace, demand and further promotion in job.
The senior staff responsible for the production and quality of pharmaceutical products in the pharmaceutical industry must have special education and practical experience in accordance with the requirements of national legislation. Its training program should include studying of the following disciplines in necessary combinations:
Chemistry (analytical, organic), biochemistry, chemical engineering, microbiology, pharmaceutical science and technology, pharmacology and toxicology, physiology and other neighboring sciences related to obligations that must be done. For example, engineers have to solve problems of maintaining and functioning of equipment, especially the processes of planned, preventive job and validation.
One of the conditions for effective educational policy of the company is a strong correlation of practical work with the educational process of learning.
Continued professional education of production workers represents the educational process which is designed to ensure the maintenance, renovation, restoration and improving level of knowledge, skills, professional training of pharmacy specialists.
The educational policy of «Scientific Center for anti-infectious drugs» represents the continued educational process that can be divided into three different areas:
First direction:
Improving the knowledge obtained at the end of institution
Specialist
Postgraduate courses
Self-study
Training in workplace
the
Fig. 4. Improving the knowledge obtained at the end of institution
The first direction is a typical approach to improving qualification of specialists who take development courses every 5 year, systematically engage in self-study, and trainings are held in the workplace with guidance of the heads of departments according to their work plans.
Second direction:
Obtaining additional education by specialty
Definition of Identifying
goals and needs for
objectives based _certain
on changing specialists factors
The choice of Educating
certain institution specialists
with an optimal -► with issuance
learning method of the
certificates
Fig. 5. Obtaining additional education by specialty
In the second direction, according to the goals and objectives which were set for the experienced production, it was necessary first of all, to retrain worked pharmacists and technicians, and secondly, to increase the number of engineers by employed chemists from other laboratories. St. Petersburg State Chemical-Pharmaceutical Academy was engaged for these purposes, which after two years of cooperation, successfully coped with this task. According to the results of this cooperation 13 specialists received diplomas of professional retraining in St. Petersburg State Chemical-Pharmaceutical Academy.
Third direction:
Continued education with academic degree
Specialist
Doctorate PhD
Fig. 6. Continued education with academic degree
The third direction involves training of production staff by break from production, associated with admission to study master and PhD programs, with possible travel to the foreign educational institutions to obtain practical skills. In this case, educating specialists do additional research work related to their diploma works.
Due to the activation of trainings in this direction within republic in recent years JSC «Scientific Center for anti-infectious drugs» decided to encourage and to help young employees who wish to continue their education.
Nowadays, only in skilled production and quality control departments there are 4 candidates in pharmaceutical and chemical sciences, four pharmacists received a master's degree, one is graduating to study in master's program, and one person is studying in PhD program. Several employees are planning to come to study in master and PhD programs in this year. Thus, the potential of production of JSC «Scientific Center for anti-infectious drugs» is equipped with enough practical and scientific staff, and continues to increase their skills through continuing education [5-6].
Continuity as a key principle of the development in professional education in the world allows us to consider learning as a process spanning the whole life of a person. It represents continued experience in mastering educational system.
Continued process of education and professional development which is based on the principle of communicative partnership and cooperation gives confidence to a specialist, and contributes to:
a) Better understanding of the practical and educational material;
b) Make the right and nonstandard decisions of communicative tasks if it's necessary.
Importance of the process of continued education and the effectiveness of the learning
process depend on successfully mastering of each individual training material. The cumulative effect of training can be obtained only when each individual lesson will be part
Master's
of the system and will give significant results in the knowledge, skills, revealing new possibilities of working professionals.
All of these points show how seriously the management of «Scientific Center for anti-infectious drugs» refers to the educational policies of the company, to professional training of specialists and to improvement system of in-company training.
It is better to understand that training is an essential component of quality during the training of staff. The world's experience shows that investment in training not only justifies itself, but also makes a profit. Management experience shows that, according to the international organization standards, if companies want to be successful, they must spend on the training of their employees not less than 2% of its annual budget.
Special staff's training of production department is the introduction of GMP standards and maintaining it after accreditation.
Educational program consists of two parts by GMP standards:
First part is a general program that all employees must participate in, which explains the importance of GMP in production. This initial training should be taken by all staff having direct impact to quality of drug.
The second part is a separate program which explains specific problems related to individual department. There is an opportunity discuss all aspects of quality and GMP with their trainers and with each other during the education. All events for implementation of educational programs are recorded and saved for review in order to guarantee that their qualifications are improving continuously. Records of training must also be saved to not involve people to work they haven't studied. People working in special areas get additional education in specific character (sterile area, areas with highly active and toxic materials, and etc.). All staff learns the rules of personal hygiene. All employees in production processes have to strictly keep them [7].
Thus, people are considered to be the main resource of any organization, so it is necessary to improve efficiency of all individual people who do their own tasks.
References
1. Azembayev A. Continued professional staff training in production of pharmaceutical companies. Journal «Vestnik» Ahunbayev, - № 3 - 2003, Bishkek - p. 107-109.
2. Azembayev A. Organization of continued education in preparation pharmaceutical production to accreditation by GMP. Materials of Scientific and Practical Conference «Topical issues of science, education and production in pharmacy», Tashkent. - 2013. -p. 370-371.
3. Azembayev A. Improving professional level of production staff. Kazakhstanskyi Farm.Vestnik - № 19. - (431). - 01.10.2013 - p. 5.
4. Spencer Lyle and Spencer Sine Competences in workplace - M.:HIPPO, 2005, p. 384.
5. Fadeeva O. V. «Concept postgraduate education of pharmaceutical workers». Magazine «Remediyum», - № 7, - 2008, Moscow.
6. Shutova T. Y. «The organization and implementation controlling system of staff in pharmaceutical companies. «Vestnik Permskoy gosudarstvennoy akademii. № 3. 2007, p. 152-155.
7. Доввдник квалiфiкацiйних характеристик професш пращвнишв: Вип. 78 «Охорона здоров'я» / М-во охорони здоров'я Украши; М-во пращ та соц. полггики Украши. — Кив, 2002. — 372 с.
