IPLUSO 19183

Quality Management

• ApresentaçãoPresentation

  This curricular unit will cover all segments related to Quality Management in the different phases of the medicine life cycle, in particular in the manufacture, registration, commercialization and post-marketing of medicines. It provides technical and scientific knowledge regarding regulatory aspects, in-depth skills and competences within the scope of Quality Control and Assurance, integrating international and national references applicable in the Portuguese Quality System.
• ProgramaProgramme

  1. Portuguese Quality System 2. Accreditation and Certification 3. Quality Management System Certification (QMS) 3.1 ISO 9000 series standards 3.2 Universal Principles of Quality Management (QA) 3.3 PDCA methodology 4. Requirements of the NP EN ISO / IEC 9001 5. Quality Management System 6. Management Responsibility, Resource Management, Product Realization / service and Measurement, Analysis and Improvement 7. QA Accreditation System for Testing Laboratories (NP EN ISO / IEC 17025) 7.1 Management requirements. 7.2 Technical request. 8. Audit Quality 8.1 Types of audits: External, Internal, Horizontal, vertical 8.2 Audit programms 9. Other Management Systems: NP EN ISO 15189; NP EN ISO 14001; OHSAS 18001.
• ObjectivosObjectives

  ¿ Provide the knowledge and tools needed to implement and maintain a quality management system. ¿ Know perform and oversee quality procedures, manage records and use the agreed terminology. ¿ To identify problems, provide solutions and help improve the quality system. ¿ Know how to use essential practices of measurement, production and analysis of data and statistical analysis to evaluate experimental data. ¿ Know how to use and understand the principles of control and quality assurance. ¿ To identify work situations nonconforming, root cause analysis, implementation of corrective actions and corrections and evaluation of the effectiveness of the measures taken. ¿ Know perform audits ¿ Find out research and analysis in national and international documentation impacting the quality management system.
• BibliografiaBibliography

  ¿ NP EN ISO 19011:2003 - Linhas de orientação para auditorias de sistemas de gestão da qualidade e/ou de gestão ambiental (ISO 19011:2002) ¿ NP EN ISO 9000:2015 Sistemas de gestão da qualidade; Fundamentos e vocabulário (ISO 9000:2015). NP EN ISO 9001:2015 Sistemas de gestão da qualidade; Requisitos (ISO 9001:2015). ¿ NP ISO/IEC 17025:2018¿ Requisitos gerais de competência para laboratórios de ensaio e calibração  
• MetodologiaMethodology

  In this curricular unit, the Team-based learning (TBL) methodology is used, with tasks carried out in small groups, allowing the development of the ability to analyze and apply theoretical concepts.
• LínguaLanguage

  Português
• TipoType

  Semestral
• ECTS

  3
• NaturezaNature

  Mandatory
• EstágioInternship

  Não