Regulatory Affairs Certification

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WHAT IS REGULATORY AFFAIRS (RAC)?

Regulatory affairs is a comparatively new profession which

developed from the desire of governments to protect public health by

controlling the safety and efficacy of products in areas including

pharmaceuticals, veterinary medicines, medical devices, pesticides,

agrochemicals, cosmetics and complementary medicines.

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Regulatory Affairs Certificate

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Regulatory Affairs Procedure

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RAC Exam Test

RAC exam is not easy to pass. Beforeattempting to take the exam, youmust have a complete knowledge ofthis. If you want to become certifiedRAC then you can get help fromExams4sure real exam material forRAC exam. Here we present the latestquestions and answers for the RACcertification exam

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RAC Exams Sample Questions

QUESTION NO: 1

Which of the following is NOT required for compliance under

21 CFR Part 11 (electronic records and electronic signatures)?

A. Manually generated time stamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records.B. Validation of systems to ensure accuracyC. Authority checks to ensure that only authorized person ll can create, modify or delete electronic records.D. Establishment of and adherence to written procedures

Answer: A

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QUESTION NO: 2

If a device failure is occurring with greater than expected

frequency and investigation of the problem indicates improper

use by the end user, which of the following should occurs?

A. The labeling is revised, B. The product is recalled, C. The product is redesigned, D. A Dear Doctor letter is issued

Answer:The labeling is revised

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QUESTION NO: 3

All of the following choices are examples of type B meetings

with FDA, except?

A. Pre IND meetings, B. Critical path meetings, C. End of Phase 2 meetings, D. Pre NDA meeting

Answer: B

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QUESTION NO: 4

The following biological products are regulated by CBER

EXCEPT?

A. Immunizing toxoids, B. Monoclonal antibodies for in vitro use, C. Monoclonal antibodies for in vivo use, D. Infusion of animal sourced cells into a hum

Answer: B

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RAC Exams Sample Questions

QUESTION NO: 5

For a medical device's product storage and handling system,

each manufacturer shall establish and maintain all of the

following EXCEPT:

A. Separate rooms or cages for release and quarantined material, B. Procedures for the control of storage areas and stock used for shipping supplies., C. Environmentally controlled areas for productD. Procedures for rotation of stock.

Answer: B

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