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RAC Practice Exam 1 Questions and Answers 100% Correct

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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...

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rac practice exam 1 questions and answers 100 cor
rac practice exam 1 questions and answers
which of the following is not required for complia

Institution RAC
Course RAC

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RAC Practice Exam 1 Questions

and Answers 100% Correct

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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