Educational guide
IDENTIFYING DATA 2024_25
Subject QUALITY MANAGEMENT Code 01737117
Study programme
1737 - MASTER UNIVERSITARIO EN PRODUCCION DE INDUSTRIAS FARMACEUTICAS
Descriptors Credit. Type Year Period
3 Compulsory First Second
Language
Prerequisites
Department ING.MECANICA,INFORMAT.AEROESP.
Coordinador
FERNANDEZ ROBLES , LAURA
E-mail lferr@unileon.es
gmedm@unileon.es
Lecturers
FERNANDEZ ROBLES , LAURA
MEDINA MARTINEZ , GABRIEL
Web http://
General description
Tribunales de Revisión
Tribunal titular
Cargo Departamento Profesor
Presidente ING.MECANICA,INFORMAT.AEROESP. BARREIRO GARCIA , JOAQUIN
Secretario ING.MECANICA,INFORMAT.AEROESP. PEREZ GARCIA , HILDE
Vocal LOPEZ RODRIGUEZ , DEIBI
Tribunal suplente
Cargo Departamento Profesor
Presidente ING.MECANICA,INFORMAT.AEROESP. MATELLAN OLIVERA , VICENTE
Secretario ING.MECANICA,INFORMAT.AEROESP. FERNANDEZ LLAMAS , CAMINO
Vocal ING.MECANICA,INFORMAT.AEROESP. ALIJA PEREZ , JOSE MANUEL


Topic Sub-topic
Block I: Quality Management Lesson 1: Quality Assurance. GMP.

Lesson 2: Organization and personnel. Human Resources. Organization chart and job description.

Lesson 3: Hygiene norms. Facilities and equipment. Requirements. Documentation. Types. Standards and files. Laboratory safety.

Lesson 4: Standards for installation and personnel. Waste management. Types of waste and regulations.

Lesson 5: Critical evaluation of personnel hygiene standards.

Lesson 6: Calibration and qualification of measuring equipment.

Lesson 7: Elaboration of standard operating procedures (SOPs).

Lesson 8: Planning of the safety standards of a quality control laboratory.

Methodologies  ::  Tests
  Class hours Hours outside the classroom Total hours
Personal tuition 7.5 0 7.5
 
Seminars 15 0 15
Assignments 15 0 15
Problem solving, classroom exercises 7.5 0 7.5
 
Lecture 25 0 25
 
Objective short-answer tests 5 0 5
 
(*)The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies   ::  
  Description
Personal tuition Individual or group tutorials. In the tutorial sessions, the professor will introduce in a personalized way -individually or in groups-, through theoretical explanations and illustrative examples, the concepts, results and methods dealt with in the subject.
Seminars Seminars, debates and/or forums. There will be an oral presentation of some specific aspect of the subject of the course, focusing more deeply on the aspects covered. This activity will enhance the ability to prospect for new lines of work and continue studying in a way that will be largely self-directed or autonomous. The contributions made by people who work in the industry and come to the classroom to contribute their experience and points of view will be favored.
Assignments Elaboration of work-projects, individually or in groups, and/or exposition of the same. The student will develop an individual work or sometimes in group to look for the bibliography/documents indicated by the professor as well as another one that will be left unexplained in some cases. This search will be in the university libraries and mostly through the Internet.
Problem solving, classroom exercises Problem solving, exercises, case studies, problem-based learning. Exercises of different complexity are solved, performing all the steps on the blackboard or on the projector. In addition, exercises will be proposed to be solved by the students. Real concrete cases will be studied as examples to be studied.
Lecture Expository Master Sessions- Each topic is presented verbally, supported by the existing audiovisual resources (projector, projector, projector, computer equipment, etc.). The concepts are justified and their application to concrete cases is shown. The student is motivated to actively participate with questions and answers, as well as the raising of issues and their resolution.

 
Description

  Description Qualification
 
Other comments and second call
Master Session: Partial and/or final objective tests. Minimum: 20 Maximum: 60
Problem solving / Exercises in the regular classroom: Exhibition and / or delivery of project work and / or practice report. Minimum: 20 Maximum: 60
Others: Complementary activities of continuous evaluation. Minimum: 10 Maximum 30.

1. BEHAVIOR IN CLASS:
In the development of the course, the student must avoid behaviors that in the opinion of the teacher are undesirable, and may be expelled from the activity otherwise. Without being exhaustive, this includes violent, sexist, homophobic, xenophobic, unhygienic behavior, improper use of electronic devices and talks not related to the subject. In particular, the making of unauthorized recordings is strictly forbidden.

2. BEHAVIOR DURING THE EXAM:
During the evaluation tests the possession and use of materials other than those explicitly approved for the development of the same is strictly prohibited. In general, the only material allowed will be pens, pencils and erasers. In particular, the possession and use of notes, books, folders and electronic devices is prohibited. Failure to comply with these rules will result in immediate withdrawal from the exam, expulsion from the exam and a failing grade. Likewise, the guidelines for action in cases of plagiarism, copying or fraud in exams or evaluation tests of the University of León will apply. If during the correction of the exams or papers, in the professor's opinion, plagiarism, copying or fraud has occurred, the above guidelines will also apply.

3. EVALUATION:
Spelling mistakes in the practical activities and evaluation tests will be negatively evaluated. If the teacher considers that in the set of tests performed one or more have been performed in an outstanding manner may increase the final grade of the student the points it deems reasonable. If the teacher considers that in the set of tests performed one or more have been performed very poorly, or not presented, may decrease the final grade of the student the points it deems reasonable.
If any of the mistakes made in any of the tests constitutes a serious misconception, the final grade of failing will be 0.0. Passing the course will require passing the theory and problem solving parts with a minimum grade. Unless expressly indicated during the development of the course, this minimum grade will be 4.0.
Students who are unable to attend the theory evaluation tests on the day they are given have the option of taking a substitute exam during the evaluation period of the first call. To do so, he/she must request it by presenting evidence of a justified reason and will be able to take it once the professor has agreed so. 

4. SECOND CALL:
In the second call, one or more evaluation tests will be carried out. The practical part will not be recoverable and the student will keep the grade he/she obtained in the first call. The theory exam of the second call will cover the whole subject. Passing the course will require passing the theory part with a minimum grade. Unless expressly indicated during the course of the course, this minimum grade will be 4.0.

5. OTHER CONSIDERATIONS.
The practices of previous years will not be kept.
The main means of communication with the professor will be face-to-face, understood as such during class attendance or tutorials.

Basic , , ,
, , ,

Marisa Ortiz, Gestión y Análisis de Riesgos de calidad: Guía práctica para la Industria Farmacéutica, Amazon Media EU S.à r.l., 2017

Complementary

J. L. Valdés, M.ª C. Alonso, N. Calso y M. Novo , Guía para la aplicación de UNE-EN ISO 14001:2015, AENOR, 2016

José Antonio Gómez Martínez, Guía para la aplicación de UNE-EN ISO 9001:2015, AENOR, 2015

 Salvador Sagrado y otros, Manual práctico de calidad en los laboratorios. Enfoque ISO 17025, AENOR, 2017