RAC Exams Questions

Regulatory Affairs Certification (RAC) Global Scope

Exam

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What is RACRegulatory Affairs Certification (RAC)

Regulatory Affairs Certification (RAC) An individual

certification for our global industry.

Regulatory affairs (RA), also called government

affairs, is a profession within regulated industries, such

as pharmaceuticals, medical devices, energy,

banking, telecom etc. Regulatory affairs also has a

very specific meaning within the healthcare

industries (pharmaceuticals, medical devices,

biologics and functional foods).

What can Regulatory Affairs do for Your Business?

I see regulatory affairs as a strategic advantage for the business because it's an extremely complex subject. It's

complex in terms of the data requirements to satisfy all

the regulatory authorities, but it's also very, very

complicated in terms of the number of product

classifications. The companies which understand all the

data requirements and all the complexities which exist

are the companies that win in the long run. - Kenneth James, senior vice president, Research &

Development

Consumer Healthcare, GSK

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RAC (US): Knowledge of US

regulations. Accredited by

the National Commission for

Certifying Agencies

(NCCA).

RAC (EU): Knowledge of

European Union

regulations.

RAC (CAN): Knowledge

of Canadian regulations.

RAC (Global): Knowledge

and critical thinking skills

related to the international

practice of regulatory

affairs, with special

attention paid to global

standards from ICH, GHTF

(through IMDRF), WHO and

ISO.

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Here are some questions

that you will get in your

exam.

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 timestamped 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 accuracy

C. Authority checks to ensure that only authorized personell can create, modify or delete

electronic records.

D. Establishment of and adherence to written procedures

Answer: A



Question No 2:

Notice of Intent to Revoke license can be issued for the following reason, EXCEPT?

A. Unable to gain access to the manufacturing plant,

B. Licensed product are no longer safe and effective

C. Failure to report serious adverse event,

D. Manufacturer fails to conform to applicable standards

Answer: C



Question No 3:

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



Question No 4:

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: A



Question No 5:

Question No 5:

Which of the following statements is TRUE for Phase 2 clinical investigations of a previously

untested drug?

A. They are designed to determine the metabolic and pharmacokinetic effects

B. They are intended to gather additional info

C. They are conducted to determine the common short-term side effects and risks associated

with the drug

D. They are performed to provide an adequate bioavailability of the drug

Answer: C



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Regulatory Affairs Certification (RAC) Global Scope

Exam

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attempt By the help of Exams4sure.net



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