1. Concepts of Quality Assurance
1.1. General Concepts of Quality Assurance
1.2. Laboratory Quality Systems (ISO 9001:2015, ISO/IEC 17025:2005, ...)
1.3. Certification vs Acreditation
2. Documentation of a Quality System
2.1. Introduction. ISO-9001 Documentation Pyramid
2.2. Quality Manual
2.3. Procedures and Instructions
2.4. Quality Records
2.5. Good Laboratory Practices (GLP). Good Manufacturing Practices (GMP)
3. Validation of Assay Methods
3.1. Regulations and Guides
3.2. Validation requirements
3.3. Standards and Reference Materials
4. Quality Control
4.1. Tools for the Quality Control
4.2. Procedures and Control Charts
4.3. Control Samples: preparation and assessment of results
4.4. Intercomparison/Intercalibration Assays
5. Quality Assurance Activities
5.1. Quality Audit. Inspections. Planifications. Reports
6. Practical Exercises
6.1. Calibration. Verification of calibration
6.2. Quality parameters calculation
The weighted aritmetic mean between the different assessment activities. Remember that it is required to obtain a minimum score of 4 in the final assessment and to perform all the small assessments along the course.
It is only possible to RECUPERATE the final assessment.
IMPORTANT: The option to participate in the recuperation of the final assessment means that the student will lose the score obtained in the first option (you will not have the option to choose the best score between the two options).
Criteris específics de la nota «No Presentat»:
Not performing any of the assessment tests and not presentingthe SOP. The presentation to one of the assessments or the SOP will not allow to obtained a "not presented" score.