GMP 2 - advanced GMP training course
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| Languages |
Dutch, German, English, French, Italian.
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| Target |
All aspects of GMP at an advanced level.
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| Quote |
'This program makes you aware that there is more involved in GMP than you think.'
Jens de Jong, team leader Yamanouchi Pharma
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| Subjects |
Cases:
- Barcode reader out of order (Example)
- Broken vials during transport
- NDA-approved suppliers
- Dealing with complaints
- Missing tablets in a blister pack
- Verification before start-up
- Documenting deviations
- An exceeded expiration date for tablets
- Preparing and filing documents
- Instruction of operators
- A deviating content in freeze-dried preparations
- Document revision
- Batch records
- Tiny metal particles found in ointment
- Contamination
- Reporting deviations
- An out of specification temperature in the autoclave
- Validation
- Calibration
- Microbial contamination
- Sudden increase in particle rate in clean room
- Non-viable particle monitoring
- Maintenance and repairs
- Contaminated media during sterile challenge
- Monitoring of the process
- Microbial checks and monitoring
- Cleaning in clean rooms
- Contaminated WFI sample
- Disinfecting and sterilisation
- Design and construction of equipment
- Revalidation
- Monitoring water
- Deviating analytical results just after validation
- Calibration and validation
- Communication
- The log
- A warning during an FDA inspection
- Inspection
- Quality assurance
- A foreign tablet in a bottle
- Line-clearance
- Accountability
- One of two containers is contaminated just before filling
- Materials reception
- Labelling
- A deviating pH during lab test
- Cross contamination
- In-process-checking
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| Didactics |
This course is a follow-up of the basic program GMP-1.
This course consists of 15 different cases. Each case analyses a production incident such as a mix up, a contamination and a FDA-warning.
The trainee must find the GMP-violation(s) causing the incident by using a checklist during the investigation. The trainee is given access to extra video fragments and documents, which might contain the mistakes.
After each case an instruction is given about the GMP rules which have been violated.
Each case ends with a test.
The course is often done by two or more trainees at a time.
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| Test |
Yes.
Each case ends with a test; the questions are from a database of 300 questions.
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| Targetgroup |
Experienced operators, team leaders en QC employees.
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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.
For each trainee a selection can be made from 15 different 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 |
6 to 8 hours (advice: maximal 3 cases per session).
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