US RAC Practice Exam 2016 Test Bank Questions and Answers All Correct (Verified Answers)
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US RAC Practice Exam 2016 Test Bank Questions and Answers All Correct (Verified Answers)
According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the:
A. Device history record.
B: Device master record.
...
US RAC Practice Exam 2016 Test
Bank Questions and Answers All
Correct (Verified Answers)
According to the Quality System Regulations, re-testing and re-evaluation of
nonconforming devices after rework activities must be documented in the:
A. Device history record.
B: Device master record.
C. Complaint files.
D. Design history file. - Explanation:
A. This contains the dates of manufactured, the quantity manufactured, the quantity
released for distribution, control numbers used and the acceptance records which
demonstrate the device is manufactured in accordance with the DMR. 21 CFR 820.184.
The correct answer is A.
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 facility with a separated air handling system from those used for other drug
products for human use.
D. Under laminar flow protection that is validated periodically. - Explanation:
C. GMP requires dedicated facilities for penicillin manufacture with separate air handling
system from other drug products used for human use. 21 CFR 211.42(d), 211.46(d).
Which of the following is NOT TRUE regarding post-approval pharmacovigilance for a
drug?
A. It is intended to detect all medically important adverse effects and uncommon safety
risks in the "real
world" of clinical practice.
B. Health professionals report all adverse drug reactions associated with the use of a
marketed drug.
C. Adverse effects from products in the same pharmacologic class as the marketed
drug must be
considered along with those for the marketed drug.
,D. Serious and unexpected adverse drug reactions in patients treated with the product
outside the United
States need to be reported within 15 days after initial notification. - Explanation:
C. A safety signal associated with products in the same pharmacologic class is also part
of post-approval
pharmacovigilance.
The correct answer is B.
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. - Explanation:
This is required by the regulations. Fair Packaging and Labeling Act, Section 4(a).
The correct answer is A.
Which type of protocol is NOT eligible for a Special Protocol Assessment under the
PDUFA?
A. Animal carcinogenicity study protocol.
B. Phase 3 clinical study protocol, which its data is the primary basis for an efficacy
claim.
C. Final product stability study protocol.
D. Bioequivalence study protocol. - Explanation:
SPAs provided in FDA's Guidance for Industry Special Protocol Assessment (May
2002), Phase Ill studies
protocols are part of the PDUFA goals for special protocol assessment.
The correct answer is D.
The marketing department has designed a journal advertisement that mentions
leadership in a particular therapeutic area and includes only the name of the company's
approved prescription drug products. Which of the following should be included in the
advertisement to be in compliance with regulations?
A. Full prescribing information.
B. A brief summary of the prescribing information.
C. All the available names of the drug product and the established name of each of the
active ingredients in the drug product.
D. A complete listing of adverse events. - Explanation:
All advertisements for any prescription drug as regulated under 21 CFR 202.1(e)(1)
require providing a
statement of information in brief summary relating to side effects, contraindications and
effectiveness.
The correct answer is C.
, A GMP audit/inspection against the requirements of 21 CFR 210/211 may include
auditing of all of the
following EXCEPT:
A. Complaint files.
B. Qualifications of consultants.
C. Pre-clinicallaboratory(ies).
D. SOPs - Explanation:
C. Pre-clinical laboratories are audited under the provisions of Good Laboratory
Practices, 21 CFR 58.
The correct answer is C.
Which of the following is true about DMFs?
A. DMFs are not reviewed until referenced by a marketing application.
B. DMFs do not require annual updates.
C. The only types of DMFs recognized by the FDA are Type I, Type II and Type III
D. A sponsor does not need written permission to reference a DMF. - Explanation:
A See 21 CFR 314.420(a) and the COER guidance entitled "Guidance for Drug Master
Files" published
September 1989.
The correct answer is A.
A sponsor submitted an original IDE/IND application. If the sponsor has not received
any response from the FDA, what is the earliest that clinical studies can be initiated?
A The sponsor must wait for FDA approvaL
B. Upon IRB approval from any study center.
C. 30 days from receipt by FDA
D. 90 days from receipt by FDA - Explanation:
C. The IDE/IND goes into effect 30 days after receipt by FDA, unless FDA notifies the
sponsor that the IDE/IND is on clinical hold. 21 CFR 812.30 (a)(1), 312.40(b)(1).
The correct answer is C.
A clinical study sponsor's representative conducts periodic monitoring site visits for all of
the following
purposes EXCEPT to:
A Review raw data.
B. Ensure compliance with the protocol
C. Review the protocol with the investigator.
D. Ensure the adequacy of the IRB and its procedures. - Explanation:
D. An institution conducting clinical investigations is responsible for the integrity of the
IRB and is held
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