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Biotech Regulatory Environment

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

By: Huda Memon
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Decks in this class (13)

Biotech Industry Overview
What is biotech,
What are the stages in the evolut...,
What is classical biotech examples
14  cards
Laws And Regulations - USDA
What is a regulatory environment,
What factors affect passage of laws,
What is true if of laws or regula...
18  cards
EPA And Other Regulatory Agencies
The environmental health mandate ...,
The us environmental protection a...,
Which federal agency is primarily...
16  cards
FDA - Biotech Food Regulations
Foods that bear poisonous substan...,
What is fda s standard definition...,
It is possible that a plant produ...
15  cards
FDA - History And Evolution Of Drug Regulation
What is the non governmental orga...,
Which of the following is least r...,
The death from children s tylenol...
15  cards
Exam 2: Stages Of Drug Development I
What is true of biologics a biolo...,
Fda defines a drug as any substan...,
Generic drugs have certain proper...
15  cards
Exam 2: Stages Of Drug Development II - Pre-clinical, GLP
According to the roche video on t...,
As part of in vitro pre clinical ...,
With fda s modenization act 20 fd...
15  cards
Exam 2: Stages Of Drug Development III - IND, Clinical Trials
What is not associated with the f...,
What was the first law that requi...,
What is not true of an investigat...
16  cards
Exam 2: GCP And Marketing Approvals - BLA, NDA, sNDA, aNDA, OTC, IDE
The study protocol is a study pla...,
What is not true of the instituti...,
What is not a role or responsibil...
15  cards
Exam 2: DEA, cGMP, ICH - The Q7A
What is true of cgmp a cgmps for ...,
What are actions taken to address...,
Cgmps are regulations that govern...
15  cards
cGMP Part II – Equipment, validation, containers and closures, process/laboratory controls, Labels
For the control of components con...,
What information would be found i...,
What is a general requirement for...
15  cards
Inspections And OSHA
Audits are periodic data based as...,
What is true about employer respo...,
What is true of osha requirements...
15  cards
Medical Device Regulation
What does not apply to medical de...,
What does not apply to the suprem...,
What does not apply to quality sy...
15  cards

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Biotech Regulatory Environment

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