Closed system fda term - Study guides, Class notes & Summaries

REHS/RS Exam Questions With 100% Correct Answers Latest Updated 2024/2025 | Graded | Verified. How is giardiasis usually transmitted to others? - Correct Answer-person-to-person transfer of cysts from the feces of the infected individual Which of the following duties of state and local health agencies is intended to ensure that the public's health and welfare are protected? - Correct Answer-Regulatory responsibilities What is a measure of the amount of light scattered by particles suspende...

Indiana MPJE Exam Questions With Correct Answers Latest Updated 2024 (GRADED) Where to find federal laws and regulations - Correct answer-United States Code (USC) The Code of Federal Regulations (CFR) Majority can be found in Title 21 of both Where to find Indiana laws and regulations (Rules in Indiana) - Correct answer-The Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - Correct answer-Prevented the manufacture, sale, or transportation of adulterated ...

SOCRA Certification Exam 154 Questions with 100% Verified Correct Answers

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider ...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

REHS/RS Exam Questions With 100% Correct Answers Latest Updated 2024/2025 | Graded | Verified. What is the most common cause for bacterial meningitis in children under five years of age? - Correct Answer-Haemophilus influenza type B How is giardiasis usually transmitted to others? - Correct Answer-person-to-person transfer of cysts from the feces of the infected individual Which of the following duties of state and local health agencies is intended to ensure that the public's health and we...

SoCRA Certification Exam Questions With Answers Latest | 100% Correct. Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. ...

Pharmacy Law MPJE Exam: Federal Law Graded A What did the Federal Controlled Substances Act do? Why was it implemented? concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Legislators very Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? Prohibited the adulteration and m...

REHS/RS Exam Questions With 100% Correct Answers Latest Updated 2024/2025 | Graded | Verified. What is the most common cause for bacterial meningitis in children under five years of age? - Correct Answer-Haemophilus influenza type B How is giardiasis usually transmitted to others? - Correct Answer-person-to-person transfer of cysts from the feces of the infected individual Which of the following duties of state and local health agencies is intended to ensure that the public's health and we...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - Yes Open system (FDA term) - System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data into CHOP - controlled datab...