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2 W HAT IS R EGULATORY A FFAIRS (RAC)? Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

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7 RAC Exam Test RAC exam is not easy to pass. Before attempting to take the exam, you must have a complete knowledge of this. If you want to become certified RAC then you can get help from Exams4sure real exam material for RAC exam. Here we present the latest questions and answers for the RAC certification exam Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

8 RAC Exams Sample Questions 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 time stamped 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 accuracy C. Authority checks to ensure that only authorized person ll can create, modify or delete electronic records. D. Establishment of and adherence to written procedures A Answer: A Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

9 RAC Exams Sample Questions QUESTION NO: 2 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:The labeling is revised Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

10 RAC Exams Sample Questions QUESTION NO: 3 All of the following choices are examples of type B meetings with FDA, except? A. Pre IND meetings, B. Critical path meetings, C. End of Phase 2 meetings, D. Pre NDA meeting Answer: B Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

11 RAC Exams Sample Questions QUESTION NO: 4 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 Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

12 RAC Exams Sample Questions QUESTION NO: 5 For a medical device's product storage and handling system, each manufacturer shall establish and maintain all of the following EXCEPT: A. Separate rooms or cages for release and quarantined material, B. Procedures for the control of storage areas and stock used for shipping supplies., C. Environmentally controlled areas for product D. Procedures for rotation of stock. Answer: B Pass Rac Exam By The Help Of Exams4Sure Get Complete File From http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html http://www.exams4sure.com/RAPS/RAC-GS-practice-exam- dumps.html

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