10 technique to Pass the Requlatory Affairs Certification
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Transcript of 10 technique to Pass the Requlatory Affairs Certification
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Regulatory Affairs Certification (RAC) Global Scope Exam
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What is RAC
Regulatory Affairs Certification (RAC)
Regulatory Affairs Certification (RAC) An individual certification for our global
industry.Regulatory affairs (RA), also called
government affairs, is a profession within regulated industries, such as
pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also
has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional
foods).
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What can Regulatory Affairs do for Your Business?
“I see regulatory affairs as a strategic advantage for the business because it's an extremely complex subject. It's complex in terms of the data requirements to satisfy all the regulatory authorities, but it's also very, very complicated in terms of the number of product classifications. The companies which understand all the data requirements and all the complexities which exist are the companies that win in the long run.” - Kenneth James, senior vice president, Research & DevelopmentConsumer Healthcare, GSK
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Pass your exam By the Help of Exams4sure
The Best Leading Site For Certified Dumps.
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RAC (US): Knowledge of US regulations. Accredited by the National Commission for Certifying Agencies
(NCCA).
RAC (EU): Knowledge of European Union regulations.
RAC (CAN): Knowledge of Canadian regulations.
RAC (Global): Knowledge and critical thinking skills related to the international practice of regulatory affairs, with special attention paid to global standards from ICH, GHTF (through IMDRF), WHO and ISO.
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The Best Leading Site For Certified Dumps.
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The Best Leading Site For Certifications
Here are some questions that you will get in your
exam.
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Question No 1:
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)?
A. Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records.B. Validation of systems to ensure accuracyC. Authority checks to ensure that only authorized personell can create, modify or delete electronic records.D. Establishment of and adherence to written procedures
Answer: A
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Question No 2:
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT?
A. Unable to gain access to the manufacturing plant,B. Licensed product are no longer safe and effectiveC. Failure to report serious adverse event,D. Manufacturer fails to conform to applicable standards
Answer: C
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Question No 3:
The following biological products are regulated by CBER EXCEPT?
A. Immunizing toxoids,B. Monoclonal antibodies for in vitro use,C. Monoclonal antibodies for in vivo use,D. Infusion of animal sourced cells into a hum
Answer: B
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Question No 4:
If a device failure is occurring with greater than expected frequency and investigation of the problem indicates improper use by the end user, which of the following should occurs?
A. The labeling is revised,B. The product is recalled,C. The product is redesigned,D. A Dear Doctor letter is issued
Answer: A
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Question No 5:
Question No 5:
Which of the following statements is TRUE for Phase 2 clinical investigations of a previously untested drug?
A. They are designed to determine the metabolic and pharmacokinetic effectsB. They are intended to gather additional infoC. They are conducted to determine the common short-term side effects and risks associated with the drugD. They are performed to provide an adequate bioavailability of the drug
Answer: C
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Regulatory Affairs Certification (RAC) Global Scope Exam
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