Printable PDFRAPS RAC-GS dumps - 100% Pass Guarantee!
Vendor: RAPS
Certifications: RAPS Certifications
Exam Name: Regulatory Affairs Certification (RAC) Global Scope
Exam Code: RAC-GS
Total Questions: 100 Q&As ( View Details)
Last Updated: Mar 14, 2025
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RAC-GS Q&A's Detail
| Exam Code: | RAC-GS |
| Total Questions: | 100 |
| Single & Multiple Choice | 100 |
CertBus Has the Latest RAC-GS Exam Dumps in Both PDF and VCE Format
- RAPS_certbus_RAC-GS_by_vbnm_96.pdf
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RAC-GS Online Practice Questions and Answers
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?
A. Utilize the STED template to complete global requirements.
B. Initiate a global submission process after all submission data are finalized.
C. Identify countries where special requirements exist during the product development phase.
D. Plan regulatory approval update meetings with senior management and stakeholders.
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.
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
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.
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. Randomization scheme and codes
B. Protocol and protocol amendments
C. ListoflECsorlRBs
D. Detailed CVofall investigators
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