Type A
|
Code |
Competences Specific | | A8 |
Analyse appropriately data and experimental results from the fields of biotechnology with statistical techniques and be able to interpret it. |
Type B
|
Code |
Competences Transversal |
Type C
|
Code |
Competences Nuclear |
Type A
|
Code |
Learning outcomes |
| A8 |
Design a quality assurance plan in a Department of clinical biochemistry.
|
Type B
|
Code |
Learning outcomes |
Type C
|
Code |
Learning outcomes |
Topic |
Sub-topic |
1. Introduction |
Introduction to quality. |
2. ISO regulations |
Accreditation and certification. |
3. ISO 9001 |
ISO 9001 regulations: organization and documents. |
4. Quality management system |
Documentation of the quality management system. |
5. Audit |
Audit of the quality management system. Steps and preparation. |
6. Good laboratory practices |
Basis of good laboratory practices. |
7. Hosting plan |
Managing the incorporation of personnel in laboratories. |
8. Sample management |
Steps in the process of collecting and managing samples in laboratories. |
9. Validation of analytical methods |
Steps to follow in the process of validation of an analysis method. |
10. Tools to control quality |
Tools and strategies used to control quality in an analytical procedure. |
Methodologies :: Tests |
|
Competences |
(*) Class hours
|
Hours outside the classroom
|
(**) Total hours |
Introductory activities |
|
1 |
0 |
1 |
Lecture |
|
20 |
29 |
49 |
Personal attention |
|
1 |
0 |
1 |
Presentations / oral communications |
|
8 |
12 |
20 |
|
Mixed tests |
|
4 |
0 |
4 |
|
(*) On e-learning, hours of virtual attendance of the teacher. (**) The information in the planning table is for guidance only and does not take into account the heterogeneity of the students. |
Methodologies
|
Description |
Introductory activities |
Quality objectives in the clinical laboratory.
|
Lecture |
Exposition of the contents of the subject: implementation of the guarantee of quality, evaluation and validation of methods, documented procedures. |
Personal attention |
Time the teacher has reserved to attend and solve doubts to the students. |
Presentations / oral communications |
Oral presentation by students of a specific subject (previous written presentation). |
Description |
manuel.suarez@urv.cat
Office 105
Department of biochemistry of biotechnology |
Methodologies |
Competences
|
Description |
Weight |
|
|
|
|
Presentations / oral communications |
|
Oral presentation by students of a specific subject (previous written presentation).
|
30% |
Mixed tests |
|
The content of the lectures will be assessed through objective multiple-choice tests.
The continuous assessment system involves to carry out two objective tests during the course. |
70% |
Others |
|
The minimum grade to pass the subject is a 4/10 for each of the methodologies evaluated. |
|
|
Other comments and second exam session |
The second call consists of an objective test that has a weight of 70%. The mark of the presentations/exhibitions are maintained. The minimum mark in each evaluation has to be a 4/10. During the evaluation tests, mobile phones, tablets and other devices that are not expressly authorized for the test, must be turned off and out of sight. The demonstrable fraudulent realization of some evaluation activity of a subject both in material and virtual and electronic support entails the student's failure mark of this evaluation activity. Regardless of this, given the seriousness of the events, the center may propose the initiation of a disciplinary file, which will be opened by resolution of the rector . |
Basic |
Badia, E, Enfoque ISO 9000: Normalización, Homologación, Certificación, Acreditación, Aseguramiento (ISO ) 9000, Editorial Deusto, 1998
Fuentes Arderiu, X, Guia per al control intern de la qualitat de la mesura de magnituds biològiques utilitzant materials de control, Associació Catalana de Ciències de Laboratori Clínic, Invitro veritas 2006
Burtis CA, Ashwood ER, Tietz Textbook of Clinical Chemistry 2nd ed, W.B. Saunders Company , Philadelphia, 2001
Fuentes X, Castiñeiras M J, Queraltó J M, Bioquímica Clínica y Patologia Molecular, Editorial Reverté, 1998
Gonzalez de Buitrago, JM, Bioquímica Clínica, Editorial McGraw-Hill , 1998
González Sastre F, Bioquímica Clínica, Barcanova, Barcelona 1993
, Sistemas de gestión de la calidad. Requisitos. (ISO 9001:2008) , Ediciones AENOR, 2008
Kaplan LA, Pesce AJ , Clinical Chemistry, Theory, Analysis, and correlation, The C.V. Mosby Company , St Louis 2009
Todd Sanford Davidsohn, Henry’s Clinical Diagnosis and Management, Saunders, Philadelphia, 2001
Compaño R, Ríos A, Garantía de la Calidad en los Laboratorios analíticos, Editorial Síntesis, 2002
Fernandez Espina C, Gestión de la calidad en el Laboratorio Clínico, Editorial médica panamericana, 2005
Departament de treball, Industria, Comerç i Turisme, Manual d’aplicació de la ISO 9001:2000 en els Laboratoris Clínics, Generalitat de Catalunya, 2003
Noblejas M, La gestión por processos en el Laboratorio Clínico según la Norma UNE-EN ISO 9001, Ediciones AENOR, 2006
Salas A, La norma UNE-EN ISO 9001 en laboratorios clínicos. Guía práctica para su implantación, Ediciones AENOR, 2009
|
UNE-EN ISO 15189:2013 Laboratorios Clínicos. Requisitos particulares
para la Calidad y la Competencia ICH HARMONISED TRIPARTITE GUIDELINE.
VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1).
International Council On Harmonisation Analytical Procedures and
Methods Validation for Drugs and Biologics. Guidance for Industry,
January 2015. Food and Drug Administration (FDA) |
Complementary |
|
http://www.acclc.cat http://www.aefa.es/ http://www.clinchem.org/ http://ifcc.org/ http://www.labtestsonline.es/
http://www.seqc.es/ |
Subjects that are recommended to be taken simultaneously |
VACCINES AND PHARMACEUTICAL DRUGS/19204206 |
|
Subjects that it is recommended to have taken before |
ANALYTICAL AND INSTRUMENTAL CHEMISTRY/19204116 |
|
(*)The teaching guide is the document in which the URV publishes the information about all its courses. It is a public document and cannot be modified. Only in exceptional cases can it be revised by the competent agent or duly revised so that it is in line with current legislation. |
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