Quality choice (GLP) <watch demo> |
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| Languages |
Dutch and English.
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| Target |
Being aware of working according to a GLP (Good Laboratory Practice) quality system.
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| Quote |
'This course provides a unique transfer of knowledge to laboratories who want to work according to GLP.'
Eric Ligtenberg, Solvay Pharmaceuticals
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| Subjects |
- Benefits of working according to a quality system
- The need to work according to GLP
- Good Laboratory Practices (GLP)
- ISO-17025
- Study file
- Study plan
- Organisation of the research
- Sufficient research capacity
- Qualified personnel
- Qualified research material
- Valid equipment
- Standard Operating Procedures (SOP
- Raw data
- Deviations (off spec)
- The need to register carefully
- Reporting
- Role of QA
- Required signatures
- Archival
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| Didactics |
The course consists of the following modules:
Module 1
Introduction GLP
Information and questions with feedback.
Module 2
Why GLP?
Each project 3 employees of 6 different laboratories explain the advantages and disadvantages of GLP; the trainee chooses the opinion he/she agrees with and receives feedback.
Module 3
7 realistic cases:
- Toxicity study (once-only research)
- Feed preparation (routine)
- Quality study breeding animals (routine)
- Water study (routine)
- Blood test (clinical)
- Bio-analysis (routine)
- Special product test (once-only research)
On the basis of video fragments the trainee is following the research. The trainee should investigate and analyse the errors made during the study with help of the study plan and the SOP's. Feedback is given on the answered questions.
The research is being influenced by:
- deviations in the research
- time pressure
- planning errors
- inadequate communication
- deviate from the SOP's
- missing SOP's
- lack of careful registration
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| Test |
Yes, testing is incorporated in the cases.
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| Targetgroup |
Project directors, lab assistants/technicians and other project employees.
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| Initiative |
Laboratories (including RIVM, TNO, Organon, Intervet and Solvay). Produced in co-operation with the Dutch GLP inspection.
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| Media |
CD-Rom
Video (75 minutes)
Photo
Audio
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| Route |
Yes.
A specific subject-selection system allows the training co-ordinator to select relevant subjects for each target group.
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| Documentation |
Yes.
The registered course data is presented in detail. Several statistics about the use and scores can be displayed. A question analysis is also available. A trainee certificate with company logo can be printed.
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| Editor |
Yes.
With the editor texts can be adapted online to meet specific laboratory circumstances.
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| Study time |
7 to 9 hours (advice: put together modules of 2 to 3 hours).
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