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RAC FINAL EXAM AND PRACTICE EXAM QUESTIONS 2024 ACTUAL EXAM COMPLETE 400 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) /ALREADY GRADED A+$18.49
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RAC FINAL EXAM AND PRACTICE EXAM QUESTIONS 2024 ACTUAL EXAM COMPLETE 400 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) /ALREADY GRADED A+
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Course
RAC 2024
Institution
RAC 2024
RAC FINAL EXAM AND PRACTICE
EXAM QUESTIONS 2024 ACTUAL
EXAM COMPLETE 400 QUESTIONS
WITH DETAILED VERIFIED
ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
RAC FINAL EXAM AND PRACTICE
EXAM QUESTIONS 2024 ACTUAL
EXAM COMPLETE 400 QUESTIONS
WITH DETAILED VERIFIED
ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
A new chemical is introduced into a manufacturing
facility. The manufacturer must ensure which of the
following documents are available for the chemical?
A. DOT manifest
B. MSDS
C. Interstate Bill of Lading
D. USP monograph - ....ANSWER...B. MSDS
A. This document is not usually required by the
manufacturer.
,B. The information contained in the MSDS must be
disseminated as mandated by OSHA regulations 29
CFR
1900.1200 (Hazard Communication) and various state
"employee right-to-know" laws. Failure to comply
may expose the company to legal risk.
C. This document is not usually required by the
manufacturer.
D. This may contain useful information about certain
chemicals, but there is no statutory mandate that
they
be available.
All of the following are additional IND submissions
to FDA EXCEPT:
A. Information Amendments
B. Protocol Deviations
C. IND Safety Reports
D. Annual Reports - ....ANSWER...B. Protocol
Deviations
,B. Protocol Deviations need to be reported to the
sponsor and are reported to the IRB, per their
individual
guidelines.
A minimum of 10 tablets is required to perform all
tests for product release. To meet GMP
requirements, retention samples must be at least:
A. 10 tablets
B. 20 tablets
C. 30 tablets
D. 100 tablets - ....ANSWER...B. 20 tablets
A. This is not a sufficient amount.
B. The reserve sample consists of at least twice the
quantity necessary for each required test. 21 CFR
211.170(a).
When assembling an NDA, all of the following
sections are required except for:
A. Bioequivalence
, B. Chemistry Manufacturing and Controls
C. Index
D. Non-clinical Pharmacology and Toxicology -
....ANSWER...A. Bioequivalence
A. Bioequivalence data is required in an ANDA, not
an NDA (21 CFR 314.94 (7).)
B. Required in an NDA. (21 CFR 314.50(d)(1).)
C. Index, or Table of Contents, is required in an NDA.
(21 CFR 314.50(b).)
D. Non-clinical Pharmacology and Toxicology is
required in an NDA. (21 CFR 314.50(d)(2).)
An NDA is required to contain copies of case report
forms for each patient who had:
A. to be hospitalized
B. a serious adverse event
C. one unexpected adverse event
D. to drop out because of an adverse event -
....ANSWER...D. to drop out because of an adverse
event
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