Quality, standardization and certification

“Quality of goods that surround us

defines the quality of our life”

Today the pharmaceutical branch demands training of experts of high level in different specialities: industrial engineers, pharmacists, analysts, clinicians, diagnosticians, and, certainly, – experts in quality management. Quality questions quickly become actual in different areas of a national economy – from the food industry to agriculture, from mechanical engineering to education. In reply to needs of the society at the National University of Pharmaceutical the specialty “Quality, standardization and certification” was opened in 1999. Opening of this direction has coincided with the general tendencies of an intensification of the European integration processes, protection of the rights of consumers, improvement of quality of domestic production and image of national commodity producers.

The overwhelming majority of graduates, who have received the NUPh diploma in a speciality “Quality, standardization and certification” for the last few years, are for today the most requested specialists, who occupy worthy posts at country leading enterprises (Joint-Stock Company NVTS “Borshchagovsky chemical-pharmaceutical factory”, Joint-Stock Company “Pharmaceutical firm” DARNITSA “, Closed Joint-Stock Company “Concern “Sterol”, Joint-Stock Company “Kiev vitamin factory”, Corporation “Arterium”,  Joint-Stock Company “Biofarma”, Closed Joint-Stock Company  “Farmak”, Limited liability company (LLC) “Pharmaceutical company “Zdorovye”, etc.). Besides, some our students fruitfully work in laboratories of the state quality assurance of medical products and other state supervising services. Many of our graduates find job at the enterprises and in the organizations of non pharmaceutical profile.

The essential increase of entrants quantity, who wish to get education in the speciality “Quality, standardization and certification”, really confirms a considerable urgency and importance of experts of such profile not only in the pharmaceutical industry. Considering this, for higher teaching level of profile disciplines and to satisfy qualified workers market needs, the  NUPh administration made a decision to create a specialized division – Department of quality management which was based in 2002 and gives the graduates “Quality, standardization and certification” specialty.

 For development of “QSC” specialty, the NUPh administration took measures for optimization of structure and information loading of the curriculum for the specialty. Work carried in this direction was based on careful viewing of curricula, and also on the analysis of changes in the international and state standards of standardization, certification, estimations of conformity, metrological activity, quality management, etc. The experience of European educational institutions and public organizations in quality sphere (for example, EOQ – European Organіzatіon of Quality) were also taken into account. The essential methodological and advisory help all this time was given by the Ukrainian Association of Quality (УАК) with which NUPh has signed the contract on cooperation.

The experience gained and new requirements of conforming standards have allowed to improve significantly educational process and methodical supply of the speciality, to prepare teachers of such directions, as quality management, metrology, standardization and certification. The essential accent at methodical editions formation is made on concepts, methods, means and procedures of creation, preparation for certification and constant improvement of quality control systems and ecological management. That is what can be expected from our graduates.

Today all lectures and the majority of practical trainings are conducted  by highly skilled senior lecturers of the National University of Pharmacy the majority of whom are certificated by the European organization of quality. Teachers of profile disciplines are operating quality auditors and have great practical experience of auditor work.

The National University of Pharmacy enrolls  students for education on “Quality, standardization and certification” specialty on two qualifying levels:

  • Specialty 8.000001 “Quality, standardization and certification”, qualifying level: master, qualification: 1238 “Master of standardization and certification and quality”.
  • Specialty 7.000001 “Quality, standardization and certification”, qualifying level: specialist, qualification: 2419.2 “Specialist of standardization and certification and quality”.

Training is carried out on full-time, evening and correspondence forms. Since 2008 experimental distant form of study is offered. The essence of such approach is reduced to dialogue of students and teachers through the Internet. On the NUPh’s server methodical materials and test for knowledge estimation, which will be accessible to students by the individual password, are placed. By means of such remote dialogue students will receive materials for disciplines mastering, corresponding explanations, tasks for self-preparation and knowledge control, and teachers will supervise work of students on each training course.

Graduates, who receive the diploma in “QSC” specialty, are the requested experts who are capable to solve problems of organizations’ activity quality improvement, to provide certification creation and preparation of certification and quality control systems development at the enterprises according to the requirements of the international standards ІSO series 9000. Such education is also necessary for experts who are engaged in standardization of new kinds of production, certification of processes, production and services, engineering specifications keeping, realization of internal audits and self-inspections, technological processes validation, personnel certification and equipment and pure premises, etc.

The NUPh’s diploma in a “QSC” specialty allows graduates to occupy a wide range of posts: directors of quality, manager of quality, the engineer of quality, the chief of quality management department, department of validation, checking department, standardization and certification expert and the internal auditor etc.

During the training general and profile disciplines, among which the following disciplines are read to students depending on the qualifying level,

  1. Cycle of humanitarian and social and economic disciplines:

• Bases of the system approach

• Conceptual computer science and information technologies

• Sociology of the organization and management

• Bases of operations research and methods of decisions making

• Modern economic theory

• Bases of the optimization theory

2. Cycle of professional and practical training

• Methodology, methods and quality control means

• Production and services standardization

• Certification and conformance acknowledgement

• Process-focused management

• Control systems of quality

• Audit of quality control systems

• Technological processes quality management

• Personnel evaluation and certification

• Social and ecological safety of activity

• Quality marketing

• Bases of ecological management

After the course at the quality management department is finished all students defend specialist degree (or, accordingly, master) work on subjects of one of actual problems in management sphere.

The curriculum on “QSC” speciality is officially admitted by the Ukrainian association of quality (UAQ) thanks to what after graduation there is a possibility for all students to receive corresponding certificates, which are a necessary condition for drawing up of test and “the Expert in quality” certificate receiving from the European organization of quality.

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