Gmp Samenvattingen, Aantekeningen en Examens
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cGMP EXAM QUESTIONS AND ANSWERS
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What does CFR and HPFB stand for? What do they do? - Answer-CFR = Code of federal regulations 
HPFB = Health products and food branch 
 
set regulations that contain the minimum requirements for cGMP 
 
What is the goal of cGMP regulations? - Answer-To have a consistent process that will lead to a safe product that is of the quality and purity that it is purported to have 
 
What are the areas that must be compliant according to part 211 of cGMP regulations? - Answer-1) General Provisions 
2) Or...
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cGMP Exam 1
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cGMP Exam 1 
 
What type of training should personnel receive in order to remain qualified for their positions? - 
In the particular operations that the employee performs 
On a continuous basis with sufficient frequency 
In current good manufacturing practice as they relate to the employee's function. 
From qualified individuals. 
 
How many qualified personnel should a company have to perform and supervise the 
manufacture, processing, packing, or holding of each drug company? - An adequate nu...
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PGMP EXAM STUDY GUIDE
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PGMP EXAM STUDY GUIDE
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Samenvatting Goederenrecht C.S. (RGMPR00306)
- Samenvatting • 54 pagina's • 2022
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Dit document is een beknopte overzichtelijke samenvatting van met name de hoorcolleges, aangevuld met de literatuur uit het boek. Ik heb het gebruikt tijdens het tentamen om snel mijn kennis op te frissen en geen aspecten te vergeten. 
 
Het is daarmee een functioneel document die de onderwerpen in hoofdlijnen in kaart brengt.
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PGMP EXAM QUESTIONS AND ANSWERS
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PGMP EXAM QUESTIONS AND ANSWERS
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PMI PGMP EXAM STUDY GUIDE
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PMI PGMP EXAM STUDY GUIDE
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PgMP EXAM STUDY GUIDE
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PgMP EXAM STUDY GUIDE
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GLP and GMP Principles Review Test 2023
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LP and GMP Principles Review Test 2023 
What does GLP stand for? - ANS-good laboratory practices 
What does GMP stand for? - ANS-good manufacturing practices 
When were biologics manufactured on a large scale? - ANS-1980 
What does CDER stand for? - ANS-Center for Drug Evaluation and Research 
What does the CDER regulate? - ANS-small molecules and drugs 
What does CBER stand for? - ANS-Center for Biologics Evaluation and Research 
What does CBER regulate? - ANS-biologics 
Which agency regulates ...
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PgMP® Exam Practice Test and Study Guide with Solutions 2023/2024
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PgMP® Exam Practice Test and Study Guide with Solutions 2023/2024
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GMP, GLP & GDP Questions And Answers 2023
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GMP, GLP & GDP 
Questions And Answers 
2023 
What is the role of OA in a GLP study? - ANS-Make sure documentation is done correctly. 
What is the role of QA in a GMP environment? - ANS-Make sure documentation is done correctly (batch 
records, SOPs) 
Work with CAPA 
What is the essence of GDP? - ANS-If it's not documented, it didn't happen. 
What is the purpose of GDP? - ANS-To prove the manufacturer did what it said it would do. 
To comply with FDA regulations. 
To discover the root cause ...
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