10 technique to pass the requlatory affairs certification

Regulatory Affairs Certification (RAC) Global Scope Exam

Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.netTo Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html

http://www.exams4sure.net/

http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html


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).

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

Pass your exam By the Help of Exams4sure

The Best Leading Site For Certified Dumps.



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.

The Best Leading Site For Certified Dumps.







The Best Leading Site For Certifications

Here are some questions that you will get in your

exam.


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





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





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





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





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





Why Choose Exams4sure?

Every student always wishes to pass his exam in first attempt and for this students struggle hard and use different dumps.Exams4sure.net is known for it's 100% accurate dumps, Quality and Value, 24/7 Customer Support on Email and Live Chat, Based on real exams Scenarios

1. Quality and Value2. 100% Guarantee to Pass Exam 3. Answers Verified by Experts 4. Based on Real Exam Scenarios5. 3500+ Exams Dumps6. 24/7 Customer Support on Mail and Live

Chat 7. 100% Lowest Price Guarantee





Regulatory Affairs Certification (RAC) Global Scope Exam

Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net







10 technique to pass the requlatory affairs certification

Documents