GMP R |
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| Languages |
Dutch and German (English in development).
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| Target |
7 new interactive GMP-courses in one lesson package.
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The GMP-lesson package contains 7 courses which can be used separately as well as combined.
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| Subjects |
Course 1: Why GMP?
- Importance of GMP
- Contamination
- Damage
- Mix-ups
- Micro-organisms
- Disinfection
- Procedures
- Checking
- Test
Course 2: Validation
- URS
- IQ, OQ, PQ
- Validation team
- Training
- Documentation
- Change Control
- Revalidation
- Test
Course 3: Change Control
- Changes
- State of Control
- Testing
- Validation
- Documentation
- CC Procedure
- Test
Course 4: Deviations
- Procedures
- Batch record
- Notations
- Being critical
- Double checking
- Reporting
- Test
Course 5: Maintenance
- Validation
- Changes
- Procedures
- Signing in and out
- Clothing
- Documentation
- Writing mistakes
- Checking
- Test
Course 6: Cleaning
- Procedure
- Cross contamination
- Order
- Refreshing cleaning water
- Clothing
- Production
- Cleaning up, disposing
- Washing hands
- Test
Course 7: Administration
- Documentation
- Locking
- Pass words
- Checking
- Audit trail
- Changes (IT)
- Updates (IT)
- Test
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| Didactics |
GMP-R is a new interactive training for the pharmaceutical
industry about GMP. The lesson package covers important GMP subjects like
validation, the importance of GMP, Change Control, deviations, maintenance,
cleaning and administration. The lesson package offers modules for new employees and new modules for experienced employees.
In short GMP-R contains:
- new lesson material for those that are already familiar with GMP-1, GMP-2 and Microlife
- material for self study as well as for group sessions
- combination of modules for specific target groups
- extra attention for validation, change control and documentation
module about maintenance and module about cleaning
- more dramatic elements
- knowledge refresher but also deepening
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| Test |
The lesson package has a separate completion test. When following several modules the participant will receive test questions applicable to the followed modules. The test results are printed on a certificate.
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| Target group |
Everyone that has followed GMP-1, GMP-2 or Micro-life (all modules), maintenance personnel (module Why GMP' and 'Maintenance'), cleaners (module Why GMP' and 'Cleaning'), office personnel (module Wh GMP' and 'Administration').
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| Initiative |
Pharmaceutical industry.
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| Route |
Yes.
Each target group follows one specific route.
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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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| Talen |
Dutch, German, English and Danish.
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| Study time |
+/- 3 hours (depending on the amount of courses that will be done).
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