RAC Questions Answers

7/17/2019 RAC Questions Answers

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What is RAC?

The Regulatory Affairs Certification (RAC) is a professional certification. The primary purpocertification program is to provide an independent assessment of the knowledge, skills and/or

for competent performance of a professional role. This assessment is typically accomplishecompletion of an examination.

A certificate training program’s primary purpose is to provide education and training so that pdefined learning objectives. Although assessment is a part of a certificate training program

conducted to evaluate the attainment of the learning objectives.



Certification

RAPS RAC-GS - Regulatory Affairs C

(RAC)RAC regulatory affairs certification is anotcertification.If you want to pass the exam in first no neeExams4sure is here for you. You can easilyprovide you the best study notes of RAC. Wdemo that will help you in your exam. Ouwe are a trust able site and all the question

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Question No 1:

Under the statutory violations, lack of an approved PMA for a PMA device in commercial distri be?

A. AdulterationB. Improper useC. MisbrandedD. Fraudulent

Answer: A





Question No 2:

MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of:1. Class I devices

2. Class II devices3. Class III devices

A. 3 onlyB. 2 onlyC. 1 and 2D. 2 and 3

Answer: D





Question No 3:

During an FDA post-submission meeting, the regulatory affairs practitioner should attempt toaccomplish all of the following EXCEPT?

A. Identify the individual with primary responsibility for the reviewB. Attempt to reach agreement on acceptability of dataC. Limit the amount of additional study requiredD. Provide testimonials from investigators

Answer: D





Question No 4:

Inspections of device components received from a supplier may frequently reveal product qualideficiencies. To avoid these instances, the supplier should first have?

A. Expert GMP knowledgeB. Clear and precise specifications from the manufacturerC. Detailed knowledge of the manufacturer's operationsD. An internal audit program

Answer: B





Question No 5:

A personal deodorant manufacturer is required to do all of the following EXCEPT?

A. Comply with GMPB. State the place of business on the labelC. List the quantity of contents on the labelD. Comply with export regulations when exporting product

Answer: A





Question No 6:

Under the official definitions of a "device," all of the following are considered devices EXCEPT?

A. X-ray filmB. Eyeglass lenses and framesC. An in-vitro diagnostic kitD. Sterilizers used for device manufacturing

Answer: D





Question No 7:

Which of the following is true regarding FDA's MDR program?

A. It is not a mandatory program for hospitalsB. It requires the manufacturer to report deaths and serious injuriesC. It does not require the report of serious injury due to malfunctionD. It requires physicians to alert FDA of device malfunctions in their personal practice

Answer: B





Question No 8:

In order to implement and maintain a Quality System, which of the following subsystems is NO

A. Production and process controlsB. Test and control article characterizationC. Pckaging and labeling controlsD. Buildings and facilities

Answer: B





Question No 9:

The following FDA submissions can be valid for a non-substantially equivalent device EXCEPT

A. Pre-Market Approval (PMA) applicationB. Investigational Device Exemption (IDE)applicationC. Special 510(k) Premarket NotificationD. Reclassification petition

Answer: C





Question No 10:

To avoid the potential for cross-contamination, FDA requires the manufacture of penicillin prod

A. In a building separated from other manufacturing buildingsB. In plants that are inspected quarterlyC. In a dedicated and validated isolation facilityD. Under laminar flow protection that is validated periodically

Amswer: C





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RAC Questions Answers