GMP 1 - Basic course Good Manufacturing Practice
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| Language versions |
Dutch, German, British-English, American-English, French, Italian, Spanish, Danish, Swedish, Portuguese, Romanian, Chinese.
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| Target |
Becoming aware of the importance of GMP.
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| Quote |
Every 3 years we train our 1600 employees with this course; for this purpose we equiped a special room with 25 computers.'
Ulrike Kaatz, Sanofi-Aventis Pharma
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| Subjects |
Module 1: Principles of GMP
- Why GMP?
- What is GMP?
- Threats of the quality
- Contamination and preventing it
- Mix-up and how to avoid it
- Damage and how to prevent it
- The need for checks
- Documentation and what it requires
- Test
Module 2: GMP-procedures
- Protective clothing + test
- Cleaning + test
- Warehouse + test
- Laboratory + test
- Clean areas + test
Module 3: Practical cases
23 practical cases in a pharmaceutical company.
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| Didactics |
In module 1 the emphasis lies on the principle: 'need to know'. The trainee has to give his/her opinion about several practical cases. This stimulates the trainee to become aware of GMP. The emphasis lies on coming to a GMP attitude (not on hammering in procedures or confronting the trainee with the GMP regulations).
Module 2 shows the main issues of the SOP's concerning protective clothing, cleaning, warehouses, laboratories and clean areas. The approach is 'drill and practice'. Specific SOP's can be linked to this.
Module 3 makes the trainee GMP-aware. Practical cases are shown and the trainee 'reacts' when something goes wrong. If the reaction is too late, the consequences are being shown tot the trainee and he/she will receive extra information.
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| Test |
1x in Module 1; 5x in Module 2; 23x Module 3.
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| Targetgroup |
Employees on operational level in companies who are obliged to work according to GMP.
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| Initiative |
Pharmaceutical industry.
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| Media |
Internet
Video (more than 2 hours)
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 meets the demands of the health inspection, including FDA.
Also several statistic analyses about the use and scores can be displayed, so that you can conclude whether the course is effective or not. 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 company circumstances. It is also possible to insert pictures.
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| Study time |
4 to 5 hours (advice: not more than 1,5 hours per session).
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