RAC Practice Exam 1 Questions and Answers 100% Correct
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Course
RAC
Institution
RAC
RAC Practice Exam 1 Questions and Answers 100% CorrectRAC Practice Exam 1 Questions and Answers 100% CorrectRAC Practice Exam 1 Questions and Answers 100% CorrectRAC Practice Exam 1 Questions and Answers 100% Correct
Which of the following is NOT required for compliance under 21 CFR Part 11 (elect...
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.
The final authority for ensuring the adequacy of an Investigational New Drug
(IND) informed consent document resides with the: - ANSWER-Institutional
Review Board (IRB)
,You have modified your 510(k)-cleared device with a Special 510(k). In which
case would a Special 510(k) not be appropriate for the device? - ANSWER-
You have changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject
to user fee exemption? - ANSWER-Real Time Supplement
A sponsor wishes to obtain permission from FDA to submit an ANDA for a
drug product that varies from the Reference Listed Drug (RLD) in route of
administration, dosage form, or strength, but anticipates that the labeling
will be identical to that of the RLD. What process should be used to apply for
that permission from FDA? - ANSWER-Suitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval
to market a - ANSWER-New chemical entity when the sponsor has a right of
reference to all applicable published studies
Distribution records for drug products must reference or contain: - ANSWER-
Name and address of the consignee
,A mid-sized pharmaceutical company negotiated with FDA to submit a draft
Package Insert (PI) and patient medication guide (MedGuide) in annotated
Word format for initial FDA review, and committed to submit the Labeling in
Structured Product Label
(SPL) format upon approval of their product. What is the preferred timeline
for this pharmaceutical company to submit the SPL formatted labeling upon
product approval? - ANSWER-14 days
Adverse event reporting for a marketed biologics product is NOT required
for: - ANSWER-Diagnostic non-invasive test kits
The quality assurance manager of a small company consisting of 12
employees is the only internal auditor for the company and has been
performing all internal quality system audits for three years. This does not
meet the requirements for performing internal quality systems audits
because - ANSWER-Auditor independence has not been ensured.
A US medical device contract manufacturer has customers for whom it
manufactures medical device components (parts) and finished medical
devices. To date, all products have been either parts for Class II medical
devices or Class II finished medical devices. The manager of new business
, contacts the regulatory manager to assess the impact of a possible new
customer
involving a Class III device. What is the first question the regulatory manager
should ask in order to begin assessing the impact of Class III on plant
operations? - ANSWER-Is it a component or device that would be
manufactured?
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
You work for a company that is developing an autologous cellular therapy
product. FDA has informed your company that your product will be regulated
as a HCT/P (Human Cells, Tissues and Cellular and Tissue-Based Product).
Based on this information, which of the following regulatory requirements
will your company need to be compliant with when manufacturing
the product? - ANSWER-All Subparts of 21 CFR 1271 except Subpart C (Donor
Eligibility)
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