09.05.2022
What has to be considered in risk management?
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18.04.2022
Which categories of documents do the EU GMP Guidelines identify?
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11.04.2022
What are the 6 different types of Excel applications?
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04.04.2022
What must the data owner ensure regarding data archiving?
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28.03.2022
From what stage in the chemical manufacturing process do GMP regulations apply?
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21.03.2022
What is the function of metadata for document management?
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14.03.2022
How do files and dossiers differ from each other?
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07.03.2022
What types of impurities may be present in chemical active substances?
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28.02.2022
What elements should be contained in a validation plan for Excel spreadsheets?
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07.02.2022
What are the requirements for advanced electronic signatures?
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31.01.2022
What is an API Starting Material?
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24.01.2022
What is meant by registration or authorisation batches?
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17.01.2022
What are the 3 designs for counterfeit-proof features?
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03.01.2022
What is the official document containing official actions sent by the FDA after a GMP inspection called?
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20.12.2021
What is an end-to-end verification system?
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13.12.2021
What is the purpose of stability testing?
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06.12.2021
What are the 3 main types of safety features against counterfeit medicines?
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29.11.2021
What is the FDA inspection report being called?
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15.11.2021
What is meant by front office and back office in the context of a GMP inspection?
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01.11.2021
What is illustrated in the V model?
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25.10.2021
What is an Establishment Inspection Report (EIR)?
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11.10.2021
What are the most important QMS areas of a GMP inspection?
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20.09.2021
When is a for-cause audit required?
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13.09.2021
What are the phases in the lifecycle of the supplier relationship?
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30.08.2021
What is the goal of supplier qualification?
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23.08.2021
What is the purpose of a qualification audit?
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02.08.2021
What is RAN and what is its purpose?
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26.07.2021
What interfaces to other quality systems does the deviation management have?
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19.07.2021
What is the European safety referral used for?
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05.07.2021
What is the purpose of line clearance?
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28.06.2021
What is the purpose of bulk filling inspection on the packaging line?
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14.06.2021
What task do code readers have on a packaging line?
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24.05.2021
For what purposes are insulators used?
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