Quality management (3971) |
| Language of instruction : English |
| Credits: 3,0 | | | | Period: quarter 1 (3sp)  | | | | | 2nd Chance Exam1: Yes | | | | | Final grade2: Numerical |
| | | Exam contract: not possible |
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Sequentiality
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No sequentiality
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The student: - can describe what quality means in a biomedical context. - can apply basic quality concepts (PDCA - 7 quality principles) in a biomedical context. - knows that different quality regulations / standards exist in a biomedical context and knows when to apply these regulations/standards. - knows the basic principles and components of a quality management system: - Quality Manual
- Process management - standard operating procedures - R&R - RACI
- Document and records management
- Training
- Problem solving - root cause analysis - CAPA
- Risk Management
- knows the difference between quality control and quality assurance- can create a SOP starting from a Turtle Diagram - knows the accreditation process and the stakeholders involved- can define an internal audit program and audit plan - can apply various methods for root cause analysis as part of problem solving - knows the difference between correction, corrective action and preventative action - can apply risk management principles- can assess the applicability of regulatory requirements for a known environment (internship) - can set up a quality management system for a given environment - can explain what method validation is and knows what parameters are important in method validation (e.g. correctness, precision, selectivity and specificity, linear and dynamic range, correlation and goodness-of-fit, robustness, limit of detection, internal standards, calibration curves, primary, secondary and third line control)
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Excursion/Fieldwork ✔
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Lecture ✔
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Project ✔
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Self-study assignment ✔
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Quarter 1 (3,00sp)
| Evaluation method | |
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| Written evaluation during teaching period | 40 % |
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| Transfer of partial marks within the academic year | ✔ |
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| Conditions transfer of partial marks within the academic year | The evaluation consists of multiple parts. For all parts of the
evaluation, at least a score of 8/20 must be obtained in order to pass
for the course.
3 tasks to be completed during obligatory working sessions (each 10% of
the grade)
1 debate (10% of grades) at the end of the working session. |
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| Written exam | 60 % |
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| Transfer of partial marks within the academic year | ✔ |
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| Conditions transfer of partial marks within the academic year | The evaluation consists of multiple parts. For all parts of the
evaluation, at least a score of 8/20 must be obtained in order to pass
for the course. |
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| Evaluation conditions (participation and/or pass) | ✔ |
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| Conditions | - The evaluation consists of multiple parts. For all parts of the evaluation, at least a score of 8/20 must be obtained in order to pass for the course. - Each student has to contribute sufficiently to the group assignment. |
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| Consequences | A student who achieves a score lower than 8/20 on one (or more) parts of the evaluation will receive a 'fail' as final result. This final result is not tolerable.
A student who scores at least 8/20 for all parts of the evaluation receives as score a weighted average of the different grades. This final mark is tolerable. Eg. 8/20 + 16/20 = 12/20 (passed)
A student who possibly has participated significantly less in the group assignment than the other group members, will follow the free-riding behavior process as explained on Blackboard. During this process, the student will receive a temporary score X (no exam grade available). If free-riding behavior is identified, the student will receive F (fail) as final score for the course, and will receive an alternative assignment during the second-chance exam period. The results of the other evaluation parts can be retained for the second-chance exam if the student has passed or had received a tolerable mark.
The working sessions are obligatory to be present. In case of a justified absence, the student will receive the grade of the group for that specific task. in case of non-justified absence, the student will receive a zero for that specific task. |
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| Additional information | When working in team, sufficient input from each student is expected. Peer evaluation is done by the Buddycheck program on Blackboard. For each student, the score of the group work will be multiplied by the factor that is calculated by this program. The method of calculation and the way this process works, is further explained on Blackboard. If there is a potentially significant smaller contribution, the process regarding free-riding behavior will be started. |
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Second examination period
| Evaluation second examination opportunity different from first examination opprt | |
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| Compulsory course material |
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Educational material will be made available on blackboard
Lectures
Educational sites with legislation and description of accreditation systems |
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Learning outcomes Master of Biomedical Sciences
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- EC
| 4. A graduate of the Master of Biomedical Sciences has knowledge of state-of-the-art techniques within biomedical research and is able to apply these techniques, taking into account the applicable quality standards. | - EC
| 7. A graduate of the Master of Biomedical Sciences takes a critical attitude towards one's own research and that of others. | - EC
| 9. A graduate of the Master of Biomedical Sciences can set up, conduct and report biomedical research in an ethical manner and with integrity, taking into account current regulations. | - EC
| KBW 2. A graduate of the Master of Biomedical Sciences specialization Clinical Biomedical Sciences has knowledge and understanding of the regulations of "Good Clinical Practice" and can apply this in practice; he / she can also design and follow up clinical studies. |
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Master of Biomedical Sciences
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- EC
| 4. A graduate of the Master of Biomedical Sciences has knowledge of state-of-the-art techniques within biomedical research and is able to apply these techniques, taking into account the applicable quality standards. | - EC
| 7. A graduate of the Master of Biomedical Sciences takes a critical attitude towards one's own research and that of others. | - EC
| 9. A graduate of the Master of Biomedical Sciences can set up, conduct and report biomedical research in an ethical manner and with integrity, taking into account current regulations. |
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Master of Teaching in Health Sciences
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- EC
| 5.2. The educational master is a domain expert HEALTH SCIENCES: the EM has an understanding of the organisation of healthcare, the policy and ethical aspects of healthcare and the interaction between different stakeholders. |
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| | EC = learning outcomes DC = partial outcomes BC = evaluation criteria |
| Offered in | Tolerance3 |
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2nd year Master of Biomedical Sciences - Bioelectronics and Nanotechnology
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2nd year Master of Biomedical Sciences - Environmental Health Sciences
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2nd year Master of Biomedical Sciences - Molecular Mechanisms in Health and Disease
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first year Master of Biomedical Sciences - Clinical Biomedical Sciences
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Master of Teaching in Health Sciences keuzetraject BMW/GEN met vakdidactiek biologie
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J
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Master of Teaching in Health Sciences keuzetraject BMW/GEN met vakdidactiek chemie
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1 Education, Examination and Legal Position Regulations art.12.2, section 2. |
| 2 Education, Examination and Legal Position Regulations art.15.1, section 3. |
3 Education, Examination and Legal Position Regulations art.16.9, section 2.
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