FDA Licensing Seminar Quiz

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FDA licensing basics

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Jocel Custodio

Philippines

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FDA Licensing Seminar Quiz


Froggy Jumps FDA Licensing Seminar QuizOnline version FDA licensing basics by Jocel Custodio 1 Which law is the FDA mandate? a RA 9711 b RA 1197 c RA 1917 2 What is GMP? a Good Manufacturing Practices b Good Morning Philippines c Great Manufacturing Practices 3 Water should be potable in a Food Manufacturing facility. a TRUE b FALSE c BALAKAJAN! 4 Food production workers need to wear this before going inside the food processing area. a PPE b BBM c PRRD 5 What should you secure before deploying an employee to the food processing area? a Health certificate or fit to work medical certificate b SOP c GMP 6 Which among the following falls under the GMP element Product Recall? a Production code/ Lot Code/ Batch coding system b Documentation Procedure c GMP Organization 7 To be able to maintain your processing standards, you need to: a Establish Procedures such as SOPs b Play Mobile Legends c Mag magic magic na lang! 8 A qualified personnel must be trained in what: a Food Safety/ GMP/ Food Handling b Fire safety c Price costing 9 As discussed, what is an LTO? a FDA issued License to Operate b Lottery c Land Transportation Office 10 For Food Manufacturers, an on-site inspection is necessary to check the establishment’s compliance with FDA laws. a TRUE b FALSE c CHAR LANG! 11 What does GMP stand for in manufacturing? a General Marketing Policy b Great Manufacturing Protocol c Good Manufacturing Practice 12 Which FDA center regulates new drug approvals? a CDER (Center for Drug Evaluation and Research) b CDRH c CBER 13 What is the primary purpose of GMP? a To ensure product quality and safety b To minimize staff training c To maximize production speed 14 Which document is typically required before clinical trials in the US? a NDA b IND (Investigational New Drug) c BLA 15 What is a Critical Quality Attribute (CQA)? a A property of a drug product that must be controlled b A marketing claim c A packaging color 16 What phase leads to marketing authorization for a drug? a Phase 3 trial b NDA approval c IND submission 17 Which is a key GMP principle? a Contamination control and traceability b Random sampling c Marketing exclusivity 18 What is the role of a GMP inspector? a Approve budgets b Verify compliance with regulations c Train staff 19 Which document outlines the manufacturing process steps? a Marketing Plan b Master Batch Record c COA 20 What does CAPA stand for? a Corrective and Preventive Action b Compliance and Audit Protocol c Certified Approved Product Arrangement

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FDA Licensing Seminar Quiz

Froggy Jumps

About this activity

Created by

Download the paper version to play

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FDA Licensing Seminar QuizOnline version

by Jocel Custodio

Which law is the FDA mandate?

What is GMP?

Water should be potable in a Food Manufacturing facility.

Food production workers need to wear this before going inside the food processing area.

What should you secure before deploying an employee to the food processing area?

Which among the following falls under the GMP element Product Recall?

To be able to maintain your processing standards, you need to:

A qualified personnel must be trained in what:

As discussed, what is an LTO?

For Food Manufacturers, an on-site inspection is necessary to check the establishment’s compliance with FDA laws.

What does GMP stand for in manufacturing?

Which FDA center regulates new drug approvals?

What is the primary purpose of GMP?

Which document is typically required before clinical trials in the US?

What is a Critical Quality Attribute (CQA)?

What phase leads to marketing authorization for a drug?

Which is a key GMP principle?

What is the role of a GMP inspector?

Which document outlines the manufacturing process steps?

What does CAPA stand for?