GMP Plus - GMP training course focussing on attitude & behaviour |
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| Languages |
Dutch, German, English and Spanish.
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| Target |
Always apply to the 10 GMP-Golden rules.
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| Quote |
'GMP is particularly a matter of attitude and that's what this course is about.'
Luc van den Broek, Janssen Pharmaceutica
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| Subjects |
Module 1:
The 10 GMP-Golden rules(= GMP+):
- Follow the instructions and be critical
- Work step by step
- State the truth and immediately
- Take your time
- Concentrate on your work
- Watch out and stay alert
- Discuss if you have doubts or obscurities
- Check twice
- Protect the product
- Protect yourself and your colleagues
Module 2:
20 Practical cases:
- Use of almost expired analysis liquid
- Emptying centrifuge in hot weather
- Sample taking after a change in the procedure
- Filling the reactor and problems with the checking
- Pump over liquid after vague instruction
- Distraction while filling in process data
- Bad communication during a shift transfer
- In a hurry while cleaning the reactor
- Putting away used tools
- Label reconciliation
- Discovering a leakage
- Spilling during filling
- Misunderstandings while adding Hydrochloric acid
- Handling deviations in cooling
- Check on purity
- Cleaning up spilled raw materials
- Working above one another
- Clothing procedures in filling rooms
- Contaminated raw materials
- Handling open products and raw materials
The course contains all the basic rules of GMP.
Module 3:
Test.
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| Didactics |
This course is a follow-up of GMP Bulk and is completely in coherence with Q7A.
If you successfully complete this course, you will know the GMP-Golden rules and know what the consequences of your mistakes could be. If you follow the GMP-Golden rules and the SOP's, you can prevent making mistakes.
In module 1 the 10 GMP-Golden rules are explained.
Module 2 consists of 20 practical cases. In each practical case a GMP rule is violated. The trainee has to discover the mistake. He/she also has to determine the cause of the mistake. He/she also should determine which Golden rules should have been adhered to more.
In the sequel to the practical case the trainee has to discover another mistake.
He/she also has to answer questions about acting correctly according to GMP.
The case ends with a video fragment that shows the correct way of acting according to GMP.
Module 3 is a test.
The course can be followed individually, but is also suitable for training in groups conducted by a supervisor.
Also available: posters of the GMP-Golden rules (for GMP awareness campaign).
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| Test |
Yes.
The trainee is only given test questions about the subjects he/she has followed.
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| Targetgroup |
Employees on executive level, primary management and laboratory employees.
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| Initiative |
Pharmaceutical industry; production companies which have to work according to Q7A.
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| Media |
Internet
Video (60 minutes)
Photo
Audio
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| Route |
Yes.
Each target group follows a specific route, with a number of practical cases (advice max. 3 cases)..
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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 company circumstances.
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| Study time |
3 to 4 hours (advice: maximal an hour per session).
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