RAC Practice Test

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RAPS RAC-GS Regulatory Affairs Certification
(RAC)
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What is RAC?
The Regulatory Affairs Certification (RAC) is a
professional certification. The primary purpose
of a professional certification program is to
provide an independent assessment of the
knowledge, skills and/or competencies required
for competent performance of a professional role.
This assessment is typically accomplished by the
successful completion of an examination. A
certificate training programs primary purpose is
to provide education and training so that
participants can attain defined learning
objectives. Although assessment is a part of a
certificate training program, the assessment is
conducted to evaluate the attainment of the
learning objectives.
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Certification
RAPS RAC-GS - Regulatory Affairs Certification
(RAC)
RAC regulatory affairs certification is another
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Here you can get 100 accurate questions of RAC
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Under the statutory violations, lack of an
approved PMA for a PMA device in commercial
distribution is considered to be? A.
Adulteration B. Improper use C. Misbranded D.
Fraudulent Answer A
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MDUFMA authorizes FDA-accredited persons to
inspect qualified manufacturers of 1. Class I
devices 2. Class II devices 3. Class III
devices A. 3 only B. 2 only C. 1 and 2 D. 2 and
3 Answer D
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During an FDA post-submission meeting, the
regulatory affairs practitioner should attempt
to accomplish all of the following EXCEPT? A.
Identify the individual with primary
responsibility for the review B. Attempt to reach
agreement on acceptability of data C. Limit the
amount of additional study required D. Provide
testimonials from investigators Answer D
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Inspections of device components received from a
supplier may frequently reveal product
quality deficiencies. To avoid these instances,
the supplier should first have? A. Expert GMP
knowledge B. Clear and precise specifications
from the manufacturer C. Detailed knowledge of
the manufacturer's operations D. An internal
audit program Answer B
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A personal deodorant manufacturer is required to
do all of the following EXCEPT? A. Comply with
GMP B. State the place of business on the
label C. List the quantity of contents on the
label D. Comply with export regulations when
exporting product Answer A
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Under the official definitions of a "device," all
of the following are considered devices
EXCEPT? A. X-ray film B. Eyeglass lenses and
frames C. An in-vitro diagnostic kit D.
Sterilizers used for device manufacturing Answer
D
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Which of the following is true regarding FDA's
MDR program? A. It is not a mandatory program
for hospitals B. It requires the manufacturer to
report deaths and serious injuries C. It does not
require the report of serious injury due to
malfunction D. It requires physicians to alert
FDA of device malfunctions in their personal
practice Answer B
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In order to implement and maintain a Quality
System, which of the following subsystems is NOT
required by FDA? A. Production and process
controls B. Test and control article
characterization C. Pckaging and labeling
controls D. Buildings and facilities Answer B
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The following FDA submissions can be valid for a
non-substantially equivalent device EXCEPT? A.
Pre-Market Approval (PMA) application B.
Investigational Device Exemption
(IDE) application C. Special 510(k) Premarket
Notification D. Reclassification
petition Answer C
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To avoid the potential for cross-contamination,
FDA requires the manufacture of penicillin
products to be? A. In a building separated from
other manufacturing buildings B. In plants that
are inspected quarterly C. In a dedicated and
validated isolation facility D. Under laminar
flow protection that is validated
periodically Amswer C
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RAPS RAC-GS Regulatory Affairs Certification
(RAC)