Quality Systems and Good Practices

Recommended Prerequisites

Pharmacy, Biology and Statistics.

Teaching Methods

Lectures and theoretical-practical are taught to enable students to grasp selective and integrated scientific knowledge. The lectures have lasting sixty minutes and follow the model of masterful lesson. In the exhibition uses the data "show." At the end of each lesson are highlighted the most relevant concepts and provided material support teaching. Simultaneously, the classes are available in “Nónio”. The practical classes lasting 2 hours to allow analysis and discussion of case studies.

Learning Outcomes

The intention of this course to impart knowledge related to the management and quality assurance in the context of scientific and technological innovation associated with the development of medicine in accordance with the requirements of ISO (9001,14001,15189), Good Manufacturing Practice, good Laboratory Practice and Good Clinical Practice.
Skills to:
- Understand and apply the rules and procedures related to Regulatory Management and Quality Assurance in order to combine its implementation to scientific and technological innovation of the medicine;
- To assess the influence of various factors (facilities, methods, people) in total quality
- Collaborate in the definition and management processes in order to improve the effectiveness and efficiency of the organization in which may be inserted;
- Participate in monitoring processes towards continuous improvement of organizations through the assessment of respective performance.

Work Placement(s)

No

Syllabus

Plenary lectures
I - Introduction to Quality Management
1. Concepts of Quality and its evolution
2. Principles of quality management
3. Quality Models
4. System quality management
5. The process approach
6. Documents system
7. Standards of Quality Management
8. Total quality
9. Future prospects

II - Formalization of a quality systemIII - Good Manufacturing Practice (GMP)
IV - Good Clinical Practice. General considerations.
V - The ISO / IEC 17025 and ISO / IEC 15189 and Laboratory Accreditation
VI - Principles of Good Laboratory Practices
VII - Environmental Management Systems / Safety and Health at Work

Theoretical and Practical
- Presentation and discussion of documents (examples) in accordance with management and technical requirements described in the standards.
- Presentation of practical cases of application of the rules studied in theoretical classes
- Visits to laboratories where the standards are applied.

Head Lecturer(s)

Filipa Alexandra Mascarenhas Melo

Assessment Methods

Assessment
Mini Tests: 20.0%
Exam: 80.0%

Bibliography

ISO 14001: 2012 – Sistema de gestão ambiental. Requisitos e linhas de orientação para a sua utilização Environmental management system. Requirements and guidelines for their use.
ISO 9000: 2005 - Sistemas de gestão da qualidade - Fundamentos e vocabulário/ Management systems quality - Fundamentals and vocabulary
ISO 9001: 2008 – Requisitos de sistemas de gestão da qualidade/ System requirements for quality management
ISO/IEC 15189: 2014 – Laboratórios Clínicos. Requisitos particulares da qualidade e competência/ Clinical Laboratories. Particular quality and competence requirements
ISO/IEC 17025: 2005 – Requisitos gerais de competência para laboratórios de ensaio e calibração Requirements for the competence of testing and calibration
Ramos Pires, A. - Qualidade. Sistemas de gestão da qualidade. 3ª ed. , Lisboa,: Sílabo, Lda. 2007.
OHSAS 18001/NP 4397 – Sistemas de Gestão de Saúde e Segurança no trabalho./ Management of Health and Safety at Work.