Study guides, Class notes & Summaries

RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions

Administrative Procedure Act federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) interstate commerce labeling 1912 Pure Food and Drug Act revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect." 1938 FD&C Act • extended control to cosmetics and therapeutic devices • required new drugs to be shown safe before marketing, beginning a ne...

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 accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Establishment of and adherence to written procedures A. The...

The _____ compressor is another positive displacement compressor and is used for larger air conditioning and refrigeration applications. Screw Compressor The four (4) major components of a vapor compression refrigeration system are the compressor, condenser, evaporator, and ________ ______. Metering device The amount of heat a refrigerant contains with -40F as the 0 heat content reference point is called Enthalpy From a performance standpoint, a substitute for R-12 is R-134A The _________...

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 accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Establishment of and adherence to written procedures - A....

Conforme o Código Brasileiro de Aeronáutica-CBA, consideram-se situadas no território do Estado de sua nacionalidade, onde quer que se encontrem, as aeronaves: - Públicas e militares O Código Brasileiro de Aeronáutica estabelece que, na prática reiterada de infrações graves, o tripulante estará sujeito a pena de: - cassação do CHT, multa de até 1000 valores de referência e suspensão do CHT No caso dos tripulantes, quais as punições que poderão ocorrer pelo Código Bra...

When soldering, flux should be applied to ________. - C. The male part of the joint only The size indicated for the diameter of copper tubing used for plumbing is the approximate __________. - C. Inside dimension When joining steel pipe, ___________ should be applied to the threads before connecting. - A. Pipe dope The maximum temp. at which soft solder is done is __________. - D. 842 F If a technician needs 5/8" ACR for an installation and was located near only a plumbing supply house...

Conforme o Código Brasileiro de Aeronáutica-CBA, consideram-se situadas no território do Estado de sua nacionalidade, onde quer que se encontrem, as aeronaves: - Públicas e militares O Código Brasileiro de Aeronáutica estabelece que, na prática reiterada de infrações graves, o tripulante estará sujeito a pena de: - cassação do CHT, multa de até 1000 valores de referência e suspensão do CHT No caso dos tripulantes, quais as punições que poderão ocorrer pelo Código Bra...

RAC EXAM WITH 100%CORRECT ANSWERS drug - correct answerAny article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - correct answerAn instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on man or o...

RAC EXAM WITH 100%CORRECT ANSWERS drug - correct answerAny article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - correct answerAn instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on man or o...

RAC PRACTICE EXAM QUESTIONS All of the following are goals of PIC/S EXCEPT: o A) Mutual recognition of inspections o B) Publication of aide-memories for medical device inspections o C) Harmonization of GMP requirements o D) Training of inspectors - correct answerAnswer: Publication of aide-memories for medical devices inspections The PIC scheme does not cover medical devices. Regulatory Reference: PIC/S 1/95 (Rev. 4) According to GHTF, key definitions and concepts for clinical evidenc...