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The targeted audience for the RAPS RAC-US certification exam is regulatory professionals involved in the pharmaceutical and medical device industries. However, candidates from any related field can take the RAPS RAC-US exam provided that they have sufficient knowledge in the area of medical devices and pharmaceuticals regulations. Individuals having designations like Pharmacist, Regulatory Scientist, Medical Device Regulatory Specialist, etc. may also apply. The RAC-US exam dumps say that Senior managers with the ability to make recommendations for a particular company's products and services are also eligible to take the exam. Chat with us now to learn more about the eligibility requirements and other requirements for this certification exam.

RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q51-Q56):

NEW QUESTION # 51
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

• A. Prepare regulatory submissions that detail the medical device's change in materials.
• B. Review the content of change and supporting data for the equivalency with the current material.
• C. Write a memo to file since the change does not impact product safety and effectiveness.
• D. No action is needed in this situation.

Answer: B

NEW QUESTION # 52
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

• A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
• B. A brief summary of relevant physical, chemical, and pharmaceutical properties:
  instructions for storage and handling of the dosage form: and a description of the formulation
• C. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
• D. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

Answer: B

NEW QUESTION # 53
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. Establish validation procedures.
• C. Assess the impact of the changes.
• D. Review the stability data for the changes.

Answer: A

NEW QUESTION # 54
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

• A. Biological activity with species and/or tissue specificity
• B. Proposed product route and frequency of administration
• C. Proposed dose and volume of administration
• D. Immunochemical and functional tests

Answer: A

NEW QUESTION # 55
Which of the following is the PRIMARY purpose of an audit report?

• A. To carry out a complete review of product applications
• B. To train sales representatives
• C. To define how to prepare new product submissions
• D. To document compliance history

Answer: D

NEW QUESTION # 56
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