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RAC Dumps

RAC regulatory affairs certification is another professional certification.<br>If you want to pass the exam in first no need to worry about now. Exams4sure is here for you. You can easily pass the exam. We provide you the best study notes of RAC. We also provide you a demo that will help you in your exam. Our demo is a proof that we are a trust able site and all the questions are approved by the experts. So what are? You waiting for just visit here for complete details: http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html<br>

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RAC Dumps

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  1. RAPS RAC-GS – Regulatory Affairs Certification (RAC)

  2. What is RAC? The Regulatory Affairs Certification (RAC) is a professional certification. The primary purpose of a professional certification program is to provide an independent assessment of the knowledge, skills and/or competencies required for competent performance of a professional role. This assessment is typically accomplished by the successful completion of an examination. A certificate training program’s primary purpose is to provide education and training so that participants can attain defined learning objectives. Although assessment is a part of a certificate training program, the assessment is conducted to evaluate the attainment of the learning objectives.

  3. Certification RAPS RAC-GS - Regulatory Affairs Certification (RAC) RAC regulatory affairs certification is another professional certification. If you want to pass the exam in first no need to worry about now. Exams4sure is here for you. You can easily pass the exam. We provide you the best study notes of RAC. We also provide you a demo that will help you in your exam. Our demo is a proof that we are a trust able site and all the questions are approved by the experts. So what are? You waiting for just visit here for complete details: http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

  4. Here you can get 100% accurate questions of RAC

  5. Under the statutory violations, lack of an approved PMA for a PMA device in commercial distribution is considered to be? A. Adulteration B. Improper use C. Misbranded D. Fraudulent Answer: A

  6. MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of: 1. Class I devices 2. Class II devices 3. Class III devices A. 3 only B. 2 only C. 1 and 2 D. 2 and 3 Answer: D

  7. During an FDA post-submission meeting, the regulatory affairs practitioner should attempt to accomplish all of the following EXCEPT? A. Identify the individual with primary responsibility for the review B. Attempt to reach agreement on acceptability of data C. Limit the amount of additional study required D. Provide testimonials from investigators Answer: D

  8. Inspections of device components received from a supplier may frequently reveal product quality deficiencies. To avoid these instances, the supplier should first have? A. Expert GMP knowledge B. Clear and precise specifications from the manufacturer C. Detailed knowledge of the manufacturer's operations D. An internal audit program Answer: B

  9. A personal deodorant manufacturer is required to do all of the following EXCEPT? A. Comply with GMP B. State the place of business on the label C. List the quantity of contents on the label D. Comply with export regulations when exporting product Answer: A

  10. Under the official definitions of a "device," all of the following are considered devices EXCEPT? A. X-ray film B. Eyeglass lenses and frames C. An in-vitro diagnostic kit D. Sterilizers used for device manufacturing Answer: D

  11. Which of the following is true regarding FDA's MDR program? A. It is not a mandatory program for hospitals B. It requires the manufacturer to report deaths and serious injuries C. It does not require the report of serious injury due to malfunction D. It requires physicians to alert FDA of device malfunctions in their personal practice Answer: B

  12. In order to implement and maintain a Quality System, which of the following subsystems is NOT required by FDA? A. Production and process controls B. Test and control article characterization C. Pckaging and labeling controls D. Buildings and facilities Answer: B

  13. The following FDA submissions can be valid for a non-substantially equivalent device EXCEPT? A. Pre-Market Approval (PMA) application B. Investigational Device Exemption (IDE) application C. Special 510(k) Premarket Notification D. Reclassification petition Answer: C

  14. To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin products to be? A. In a building separated from other manufacturing buildings B. In plants that are inspected quarterly C. In a dedicated and validated isolation facility D. Under laminar flow protection that is validated periodically Amswer: C

  15. You can pass the exam in first attempt Exams4sure is the key to your success

  16. RAPS RAC-GS – Regulatory Affairs Certification (RAC)

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