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Kate Bailey
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Decks in this class (31)
Annex 21
Annex 21,
Where does annex 21 not apply,
Can manufacturing operations be r...
6
cards
Recent Updates
Critical medicines alliance
1
cards
Where To Find
Guidance on packaging and labelling,
Guidance for cleaning validation,
Guidance on oos
5
cards
MRA
Mra countries mhra list of author...,
The products not included in the ...,
Where do you find countries and s...
8
cards
International Recognition Procedure
Tell me about the irp,
What are the key features of the ...,
Tell me about the key features of...
5
cards
API Importation
White list countries mhra list of...,
What are the rules around importa...
2
cards
Legal And Operational Duties Of The QP
What are the operational duties o...,
Legal duties of a commercial qp,
Legal duties of an imp qp
3
cards
Registration
What are the mhra authorisation r...,
What happens if you are centrally...,
Describe the difference in regist...
6
cards
ICH Q9
Provide a summary of ich q9
1
cards
FMD
Can you talk me through the fmd a...,
What products is the fmd applicab...,
Is the fmd applicable for vet pro...
5
cards
MHRA
Describe the structure of the mhr...,
2
cards
ICH Q10
What is the purpose of ich q10,
What is the objective of ich q10,
What is the scope of ich q10
4
cards
Guidance
What is the basic structure of eu...,
What documents are found in part ...
2
cards
PQS
What would be in a technical agre...,
What is the structure of the pqs,
How do you know if it is an effec...
28
cards
Product quality review
What is your understanding of pqr...,
How are statistics used in the re...,
What is the purpose of a product ...
4
cards
Recall
What are the recall classifications,
For a class 1 recall at what leve...,
For a class 2 recall at what leve...
17
cards
Brexit
Nimar,
Northern ireland protocol,
Windsor agreement
5
cards
Annex 1
Overview of annex 1,
What are the principles of annex 1,
What section of annex 1 is pqs
9
cards
ICH
Ich q2 r2 contents,
Ich q14 contents,
Ich q2 update
7
cards
HMR
Tell me about the mhr,
What parts make up the hmr,
Name some of the schedules in the...
5
cards
CTR
Tell me about the ctr
1
cards
Annex 13
What is annex 13
1
cards
PICs
What is pics,
The aims and objectives of the pi...,
The pic is administered by
6
cards
Parallel Imports
Definition of a parallel import,
Parallel imports concerns,
Pi the regulatory position
8
cards
Clinical trials application
Eu clinical trial regulation ctr,
Combined review service for ct ap...
5
cards
Northern Ireland Supply
What is the ni protocol,
European commission 17 december 2...
10
cards
Annex 16
Batch release is a 3 step process,
Sampling outside of eu need techn...,
Three points the qp must ensure i...
4
cards
QP code of practice
What is the qp code of practice
1
cards
Supply chain
Supply chain answer,
Supply chain api moving to a thir...,
Supply chain bulk tablets moving ...
4
cards
Regulatory Agencies
Who are mhra and what do they do,
Who are ema and what are they res...,
Who are pic s
7
cards
Law basics
2001 83 ec article 51 si 2012 191...,
2001 20 ec article 13 si 2004 103...,
Gdp guidelines
96
cards
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Law and Admin
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