Laboratory Quality Control
Code
11266
Academic unit
Faculdade de Ciências e Tecnologia
Department
Departamento de Química
Credits
3.0
Teacher in charge
Elvira Maria Sardão Monteiro Gaspar
Weekly hours
2
Total hours
28
Teaching language
Português
Objectives
The course will include fundamental aspects of good practices in laboratory, the laboratory organization and procedures. It will include legislation (ISO 17025 and ISO 9001).
The quality parameters, sampling and sample management will be also focused. Calibration procedures, method validation, Certified Reference Materials, validation of results and and the requirements for analytical quality as well as the process of lab quality audit will be taught.
Prerequisites
Basic knowledge in analytical chemistry
Subject matter
1. Quality control: concepts, organization, procedures and objectives.
2. Control and Quality Assurance - advantages. Terminology. Analytical methods - General principles and choice.
3. Analytical method validation.
4. Audits - internal and external audits.
5. Statistics for Analytical Chemistry and Quality Control.
6. Introduction to the presentation of results. Errors: classification and determination. confidence interval. Comparison of accuracy. Comparison of methods.
7. Data processing - Comparison of results.
8. Laboratory Records and Reports.
Invited Presentations:
Quality control in the laboratory of the regulatory body of the pharmaceutical industry.
Quality control in the laboratory of responsible entity by the waters, EPAL.
Quality control in the laboratory of the entity responsible for environmental control, APA.
Bibliography
Statistics and Chemometrics for Analytical Chemistry, Fifth Edition, James N. Miller, Jane C. MillerPearson Education Limited, Essex CM20 2JE, England.
Ronald Christensen, “Analysis of Variance, Design and Regression”, Chapman & Hall/CRC, 1998
Pedagogical issues and tools will be given to the students during the course.
Teaching method
Theorical classes and seminars given by experts from entities where Quality Control is legally imposed. Student groups working under a theme involving all the concepts and course knowledge.
Evaluation method
a) 1 Test and/or exam to evaluate concepts and theoretical aspects of Quality Control. (T/E) (> 9.5 val.)
b) Oral Presentation (.ppt) and Discussion. (OP) (> 9.5 val.)
Final evaluation: [0.4 x T/E ] + [0.6 x OP]