What is 21 cfr 11 - Study guides, Class notes & Summaries
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Major Field Test Questions and Answers Graded A+
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Major Field Test Questions and Answers 
 
Graded A+ 
 
1. Important professional attributes of aviation professional does not include 
 
2. The FAA specifically requires applicants for which airmen certificates to "be of good moral 
character Per 14 CFR 61.153(c) candidates for an ATP license must "be of good moral 
character". 
 
3. The potential penalty for falsifying records such as FAA knowledge test results or logbook 
entries include: The applicable airmen certificate can be suspended ...
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US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified)
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US RAC Review Questions RAPS Modules With Complete Solutions Latest 2023/2024 (100% Verified). drug, which of the following studies would typically be conducted 
first: 
A) 1 month repeat dose toxicology study 
B) Single dose escalation PK study in healthy volunteers 
C) Multiple dose PK study in healthy volunteers 
D) Single dose escalation study in hypertensive patients: B) Single dose 
esca- lation PK study in healthy volunteers 
3. A sponsor must report an unexpected, fatal or life...
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SOCRA Exam Questions and answers already graded A+| Updated & Verified | 2024
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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 the elect...
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DOT QUESTIONS AND ANSWERS FULLY SOLVED
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DOT QUESTIONS AND ANSWERS FULLY SOLVED 
1. Which of the following is true? 
 
 
*The FMCSA does not consider feasibility or impact in the rule-making process. 
 
*Only the Medical Review Board can provide advice and opinions on FMCSA rulemaking. 
 
*FMCSA medical standards and guidelines are subject to public notice and comment rulemaking. 
 
*The Code of Federal Regulations provide guidance that the medical examiner may or may not follow. 
FMCSA medical standards and guidelines are subject to p...
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Exam (elaborations) SOCRA certification / LATEST EXAM PREDICTIONS UPDATES, APPROVED.
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SOCRA CCRP Exam Practice Questions 
and answers, VERIFIED/ 
21 CFR part 11 regulates? - -Electronic Signatures 
What is the name of FDA Form 483? - -Inspectional Observation 
What does 21CFR56 regulate? - -Institutional Review Boards 
An application for Investigational Device Exemption is part of 21 CFR part ____________? - -812 
Define Electronic Signature - -A computer data compilation of any symbol or series of symbols 
executed, adopted, or authorized by an individual to be legally binding...
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RAC Practice Exam 1 | Questions with 100% Correct Answers | Verified | Latest Update 2024
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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. 
T...
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OSHA 30 CONSTRUCTION TEST ANSWER KEY INTRODUCTION TO OSHA – LATEST VERSION ALREADY PASSED
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OSHA 30 CONSTRUCTION TEST 
ANSWER KEY INTRODUCTION TO OSHA 
– LATEST VERSION ALREADY PASSED 
 
The CFR Parts, such as Part 1926 for Construction, are further broken down into ___________, 
which group together specific and detailed standards. 
 
A. Bullets 
B. Pieces 
C. Slices 
 
D. Subparts D. Subparts (correct answer) 
 
Get OSHA 30 Exam Passed - 
 
1. When the employer receives an OSHA citation, it must be: 
 
A. Contested and filed with the courts 
 
B. Copied and mailed to each worker 
C...
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RAC Practice Exam 1 | Questions with 100% Correct Answers | Verified | Latest Update 2024
- Exam (elaborations) • 18 pages • 2023
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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. 
T...
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CITI Training Exam Review Questions With Complete Solutions Latest Update 2023-2024 (Graded A+)
- Exam (elaborations) • 13 pages • 2023
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CITI Training Exam Review Questions With Complete Solutions Latest Update (Graded A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, 
Clinical Development (Phase I-III), NDA submission, 
Marketing (Phase IV) 
When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases 
(human trials). *30 day process. 
What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV 
marketing phase. 
How long does th...
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NRCME-Exam Questions and Answers 100% Verified
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NRCME-Exam Questions and Answers 
100% Verified 
What are regulations? - answerLaws that must be followed 
What are disqualifying medical conditions? - answerEpilepsy 
monocular vision 
hearing loss 
What are guidelines? - answerRecommendation to follow but can have raptor ale for 
variation 
FMCSA medical program responsibilities include: 
Oversee the Department of Transportation. 
Regulation of intrastate commercial motor vehicle operations. 
Conduct and oversee the agency's medical exemption...
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