Free RAC-US Exam Braindumps certification guide Q&A [Q32-Q47]

NO.32 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?

NO.33 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?

NO.34 During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

NO.35 A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

NO.36 Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

NO.37 A company receives multiple complaints regarding the text included on a recently launched product’s label. What action should the regulatory affairs professional take FIRST?

NO.38 Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

NO.39 When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

NO.40 SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

NO.41 According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

NO.42 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?

NO.43 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?

NO.44 Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

NO.45 Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y’s products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

NO.46 As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

NO.47 Which of the following situations does NOT require rapid communication to regulatory authorities?