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A quick overview of the RAPS RAC-US Certification Exam:
Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.
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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q41-Q46):
NEW QUESTION # 41
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
- A. Stop product manufacturing.
- B. Assess the impact of the changes.
- C. Review the stability data for the changes.
- D. Establish validation procedures.
Answer: A
NEW QUESTION # 42
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- B. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
- C. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
- D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
Answer: C
NEW QUESTION # 43
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Request documentation from the sub-contractor.
- B. Ask the vendor to take responsibility.
- C. Document and perform audits.
- D. Request an inspection from a regulatory authority.
Answer: C
NEW QUESTION # 44
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Revision history
- B. Scope and level of detail
- C. Expiration date
- D. Relevance to regulations
Answer: D
NEW QUESTION # 45
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Assess the potential safety risk.
- B. Withdraw the affected product from the markets.
- C. Notify the global regulatory authorities.
- D. Send a "Dear Dr." letter to customers.
Answer: C
NEW QUESTION # 46
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