This class was created by Brainscape user Huda Memon. Visit their profile to learn more about the creator.

Decks in this class (13)

Q1
Regulations and guidelines enforc...,
Vioxx was an arthritis pill linke...,
A horse named ____________was use...
10  cards
Q2
Which of these are not a regulato...,
Strictness of cgmps increase as d...,
What is the umbrella term that we...
10  cards
Q3
The purpose of a sight glass is t...,
Per the 1st takeda link confirmat...,
When referencing cfrs if you want...
10  cards
Q4 W5
Completed documentation should be...,
This diagram consists of all the ...,
What is an additional part of the...
10  cards
Q5 W6
Yield calculated electronically d...,
Deviation description justificati...,
______________________was made to...
10  cards
Q6 W7
Qa is who designates a batch appr...,
Date time lot number product sign...,
Batch distribution records must b...
10  cards
random CFRs and dates
21125 1,
21128 2,
21142 3
26  cards
Q7 W8
_____________ are promptly inform...,
Cfr 21 part 211 subpart h section...,
Sales of drug product can be made...
13  cards
Q8 W9
Computer validation is similiar to 1,
Which of these are true 2,
At which stage will you need to c...
10  cards
ICH
Ichq10 1,
Ichq8 2,
Qtpp 3
8  cards
Q9 W11
Your process must be reliable rep...,
__________________ is a deviation...,
Batch history distribution range ...
10  cards
Q10 W12
Fda auditors and consultants must...,
Full inspections and abbreviated ...,
Profit seized or given up as cons...
10  cards
Exam 3
________________ prevents cases o...,
Method validation can only be cre...,
Ich guidances became mandatory fo...
5  cards

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BTEC 3321

  • Class purpose General learning

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