Rac practice exam update - Study guides, Class notes & Summaries

US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in regulatory terms? It involves two or more regulated components, such as a drug and device, that work together. Explain what an Orphan Drug Designation provides to a company. It grants incentives lik...

RAC Practice Exam 1 2024 | 93 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ 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 c...

RAC Exam practice 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Subst...

OCI Foundations Practice Exam (1Z0-1085) Questions and Answers | 2024 Update What does compute instance vertical scaling mean? -Answer-Changing to large or smaller shape - New shape must have the same hardware architecture Which resource do you manage in IaaS? -Answer-Middleware Operation System Runtime Data Apps A company has developed a payroll app in OCI. What should they do to ensure the app has highest level of availability and resilience? -Answer-Deploy across multiple ADs and R...

2024 RAC Practice Exam | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. - C. 30 calendar days. Serious inju...

RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass What is the primary purpose of regulatory affairs? A) To ensure product marketing strategies are effective B) To ensure compliance with laws and regulations in healthcare C) To manage sales and distribution D) To enhance customer service practices Which of the following is a common requirement for premarket approval of medical devices? A) Completion of an annual report B) Submission of clinical data...

OCI Foundations Practice Exam (1Z0-1085) Questions and Answers | 2024 Update What does compute instance vertical scaling mean? -Answer-Changing to large or smaller shape - New shape must have the same hardware architecture Which resource do you manage in IaaS? -Answer-Middleware Operation System Runtime Data Apps A company has developed a payroll app in OCI. What should they do to ensure the app has highest level of availability and resilience? -Answer-Deploy across multiple ADs and R...

OCI Foundations Practice Exam (1Z0-1085) Questions and Answers | 2024 Update What does compute instance vertical scaling mean? -Answer-Changing to large or smaller shape - New shape must have the same hardware architecture Which resource do you manage in IaaS? -Answer-Middleware Operation System Runtime Data Apps A company has developed a payroll app in OCI. What should they do to ensure the app has highest level of availability and resilience? -Answer-Deploy across multiple ADs and R...

OSHA 30 Construction EXAM FULL & REVISED Answer Key MANAGING SAFETY AND HEALTH Latest Update. Terms in this set (73) IIPP is an acronym for ______________________. A. Incident Program Plan B. Injury and Impairment Planning Program C. Injury and Illness Prevention Program D. None of the above C. Injury and Illness Prevention Program (correct answer) Get OSHA 30 Exam Passed - OSHA recognizes that the implementation of a safety and health program as a way of demonstrating ____________ in...

Division Officer Fundamentals BDOC Exam 137 Questions with Verified Answers What are the Responsibilities of the DH? - CORRECT ANSWER -Organize and train the dept for battle readiness (damage control, PQS, and watches) - Assign personnel to stations and duties. -Oversee department administration and record review, for the organization and operation of the dept. -Coordinate the department safety program with the unit's safety officer. - Inspect personnel, material and assigned spaces of d...