Regulatory Affairs Certification (RAC) Global Scope

Exam
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Regulatory 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 is RAC

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 (CAN): Knowledge

of Canadian regulations.

RAC (EU): Knowledge of

European Union
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

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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

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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

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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

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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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Pass RAC (Regulatory Affairs Certification) in first

attempt By the help of Exams4sure.net

Regulatory Affairs Certification (RAC) Global Scope

Exam
Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net
To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html