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Preparations of RAC-GS Exam 2021 RAC Regulatory Affairs Certification Unlimited 100 Questions
NEW QUESTION 40
Which of the following is the PRIMARY purpose of an audit report?
- A. To carry out a complete review of product applications
- B. To document compliance history
- C. To define how to prepare new product submissions
- D. To train sales representatives
Answer: B
NEW QUESTION 41
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. As many as required by international standards
- B. The minimum number of attendees necessary to address the issues
- C. All senior management from the main office
- D. As many as government attendees
Answer: B
NEW QUESTION 42
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Documented agreement
- B. Early collaboration
- C. Follow-up meeting after submission
- D. Frequent communication
Answer: D
NEW QUESTION 43
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a
holiday season when most of the staff Is not available. What is the MOST practical approach to this
dilemma?
- A. Arrange for an inspection without all intended personnel.
- B. Inform the authority that the time is not suitable and request a new time
- C. Negotiate with colleagues and the authority to find a better time.
- D. Insist that key personnel be available for the inspection.
Answer: C
NEW QUESTION 44
Which of the following BEST describes the process of post-marketing surveillance for healthcare
products?
- A. Vigilance procedure to notify the regulatory authorities about serious incidents
- B. Systematic procedure to review published scientific journals
- C. Systematic procedure to review experiences with the products in use
- D. Vigilance procedure to ensure the full traceability of the products
Answer: D
NEW QUESTION 45
A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?
- A. Specification
- B. Justification
- C. Formulation
- D. Property
Answer: B
NEW QUESTION 46
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a
regulatory affairs professional to become involved?
- A. Product release and validation
- B. Concept development and validation
- C. Early technical design and product release
- D. Concept development and early technical design
Answer: D
NEW QUESTION 47
A materials supplier informs a company that it intends to stop supplying a material critical to the
manufacture of the company's products. What action should the company take FIRST?
- A. Complete a gap analysis to identify options.
- B. Reformulate the products with a replacement material.
- C. Review the company's existing Quality Management System
- D. Qualify another supplier and execute a supplier agreement.
Answer: D
NEW QUESTION 48
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?
- A. The ISO national member body
- B. The ISO Secretariat
- C. The country's regulatory authority
- D. The ISO technical committee in charge of the area
Answer: A
NEW QUESTION 49
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be labeled on the outside of the shipping package that it is intended for export.
- B. The product must not be sold or offered for sale in domestic commerce.
- C. The product must not be in accord with the specifications of the foreign purchaser.
- D. The product must not be in conflict with the laws of the country to which it is intended for export.
Answer: D
NEW QUESTION 50
The requirements for document control are located in which of the following documents?
- A. IEC 60601
- B. ISO 13485
- C. WHO guidelines
- D. ICH guidelines
Answer: B
NEW QUESTION 51
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the
manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Clinical affairs
- B. Quality improvement
- C. Quality assurance
- D. Regulatory agency
Answer: C
NEW QUESTION 52
A regulatory affairs professional has submitted a package for regulatory review. According to the
regulation, the regulatory authority will need to respond within 90 days of submission. If there is no
response after the deadline, what is the BEST approach?
- A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions. - B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made
regarding the submission. - C. Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission. - D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time.
Answer: A
NEW QUESTION 53
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Obtain regulatory documents and history and provide the information to R&D.
- B. Summarize regulatory documents and history and provide the information to the management team.
- C. Obtain competitor research and provide the information to the management team.
- D. Ask the trade association representative to provide an overview of the new product area to the
marketing team.
Answer: B
NEW QUESTION 54
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left
alone in the records room. The records room contains information on all products produced by the
contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Deny the auditor access to the room and retrieve only the requested records.
- B. Allow the auditor accompanied access to the room to retrieve the records.
- C. Allow the auditor access to the room and records due to the current audit.
- D. Deny the auditor access to the room and records due to confidentiality concerns.
Answer: B
NEW QUESTION 55
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