Master in Pharmaceutical Engineering

Quality Management Systems

ECTS

6

Learning outcomes

Familiarise course participants with the concepts, requisites and documentation related with quality and environmental management systems. Supply the necessary materials and tools in view of establishing quality and environmental management systems and the required methodology to implement an integrated management system. Contextualise the establishment of quality management systems in the referential framework of the pharmaceutical industry and related activities (GMP and GLP).

Syllabus

  1. Quality Management: ISO 9000:2000; Documentation associated with the management system of Quality; Quality Methodologies-Process approach; Customer satisfaction; suppliers evaluation, 6 sigma methodology; Capacity Analysis
  2. Environmental Management: ISO 14001
  3. GLPs, Good Laboratory Practices
  4. GMPs and their applicability in the context of the Pharmaceutical Industry
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