Closed system fda term Study guides, Class notes & Summaries

IL MPJE A ALREADY GRADED A+ What is the Drug Enforcement Administration (DEA) responsible for? ️Enforcing federal controlled substances laws What Illinois organizations are responsible for monitoring and enforcement of the Illinois act? ️-The Department of Human Services -Office of Alcoholism and Substance Abuse -Department of Financial and Professional Regulation Are controlled substances regulated by federal or state laws? ️Both federal and state What if state law and federal...

MPJE Illinois Complete Answers Agency responsible for monitoring and enforcing the Illinois Act ️Department of Human Services Office of Alcoholism and Substance Abuse Department of Financial and Professional Regulation The DEA is part of which organization? ️DOJ What is another name for the Comprehensive Drug Abuse Prevention and Control Act of 1970? ️Controlled Substance Act What did the Controlled Substance Act do? ️Gave FDA authority to determine scheduling of controll...

IL MPJE Rickert Verified Answers What is the Drug enforcement administration responsible for? ️Enforcing federal controlled substances laws What Illinois organizations are responsible for monitoring and enforcement of the Illinois act? ️The Department of Human Services, Office of Alcoholism and Substance Abuse, and the Department of Financial and Professional Regulation What does the Comprehensive Drug Abuse Prevention and Control act of 1970 entail? ️Gave FDA authority to de...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - CORRECT ANSWER-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 ? - CORRECT ANSWER-Yes Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (...

Indiana MPJE review Exam Questions And Answers With Latest Solutions Where to find federal laws and regulations - answerUnited 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) - answerThe Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - answerPrevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or delete...

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. ...

Indiana MPJE review Exam Questions And Answers With Latest Solutions Where to find federal laws and regulations - answerUnited 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) - answerThe Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - answerPrevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or delete...

SoCRA Certification Exam Questions With Answers Latest (100% Correct) 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. 11.3) Digita...

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 ...