RAPS RAPS Certifications RAC-GS Questions & Answers

• Question 51:

  At a recent scientific meeting,Company Y had two booths:

  At one booth,Company Y provided brochures on a completed Phase II study.

  In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.

  A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

  A. Acknowledge receipt of the letter in a written response but do nothing further.

  B. Inform the legal department of the letter and discuss how to respond.

  C. Inform Company X that it has no right to send such a letter and do nothing further.

  D. Inform the local regulatory authority of the letter and discuss how to respond.

  Correct Answer: BD

• Question 52:

  Who has the PRIMARY responsibility for recall of products with quality defects?

  A. Consumer

  B. Distributor

  C. Manufacturer

  D. Regulatory authority

  Correct Answer: C

• Question 53:

  SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

  A. Inadequate training

  B. Late and/or incorrect deliverables

  C. Causes of non-conformities

  D. Adverse environmental impacts

  Correct Answer: C

• Question 54:

  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 technical committee in charge of the area

  C. The ISO Secretariat

  D. The country's regulatory authority

  Correct Answer: AD

• Question 55:

  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. Allow the auditor access to the room and records due to the current audit.

  B. Allow the auditor accompanied access to the room to retrieve the records.

  C. Deny the auditor access to the room and retrieve only the requested records.

  D. Deny the auditor access to the room and records due to confidentiality concerns.

  Correct Answer: B

• Question 56:

  A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

  A. Adverse event reports

  B. Clinical experience

  C. Clinical investigations

  D. Literature search

  Correct Answer: C

• Question 57:

  The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

  A. Production

  B. Analytical

  C. Quality

  D. Regulatory

  Correct Answer: CD

• Question 58:

  Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.

  What should the regulatory affairs professional do FIRST to meet the new requirement?

  A. Contact the trade association for advice.

  B. Communicate with the relevant internal departments.

  C. Prepare documents for the files.

  D. Request a permanent waiver from the new regulation.

  Correct Answer: B

• Question 59:

  Which of the following is MOST appropriate for the purpose of lot release of biologics?

  A. Inventory control

  B. Safety assurance

  C. Efficacy confirmation

  D. Quality verification

  Correct Answer: D

• Question 60:

  Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

  A. Before the enactment of the regulation, through the industry representative

  B. Before the enactment of the regulation, through formal comments gathering process

  C. After the enactment of the regulation, through the industry representative

  D. After the enactment of the regulation, through a product-specific meeting

  Correct Answer: B