Holygrams

drug - Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - An 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 other animals intended to affect the structure of any function of...

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 Substances Act d) Kefauver-Harris Amendments (1:2) - D: Kefauver-Harris Amendments

Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. 505 (B) 1 &2 - 21 CFR 314.54 WHAT CAN'T BE SUBMITTED AS 505(B)(2) APPLICATIONS? - · An application that is a duplicate of a listed drug and eligible for approval under section 505(j) (see 21 CFR 314.101(d)(9)); or,

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.

device - instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: -recognized by NF-USP -intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease -intended to affect the structure or function of the body -not achieving any primary purpose through chemical action -not dependent on metabolism for primary purpose

nasc/nat - birth/born mentor words: nation, international ten/tain - hold mentor words: contain, retain fer - carry/bear mentor words: ferry, transfer

Side A - Side B 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 of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR

Diagnostic imaging - Radiology, nuclear med, photography, mico imaging, and other types Radiography - Most common subspecialty. It uses x-rays to produce a diagnostic imaging. X-rays - Are a form of invisible radiation. Produced when a positively charged metal plate inside a vacuum is bombarded with a stream of electrons.

What do you create using cones? - The Diamond of Safety Tugs are not allowed within the aircraft. - 5 feet How many cones create the Diamond of Safety? - 6 Before entering the Diamond of Safety you must ? - Safety Stop

1.) Which of the following is NOT a component of RAMP certification? A. Owner/Manager Training B. Server/Seller Training C. New Employee Orientation D. Signage E. Affidavit Request for RAMP Certification F. ALL of the above are RAMP components - F. ALL of the above are RAMP components

(S1) If you started your first alcohol server job after August 8, 2016, you must be re-trained in the RAMP Server/Seller class before your current training expires. - True (S1) Signage required for RAMP Certification MUST include which of the following information: - A and B only (S1) A benefit of RAMP Certification for the licensee is a possible reduction in the fines and penalties issued by an Administrative Law Judge to the licensee for serving a minor or a visibly intoxicated patron. -...

RAMP server / seller training is for all new alcohol service personnel hired after August 8, 2016. - .mandatory It is recommended that new employee orientation be completed on or before the first day of employment as a member of the licensee's alcohol service staff. True or False? - True

Allegiant's highest priority and your most important job is - Safety Safety must Guide your every , and - Act Action Reaction Who is responsible for ramp safety? - I Am When is the only time it is permissible to run - immanent danger

What is the new one focus on the ramp? - Safety Never come closer that feet to an aircraft, except with loading equipment/devices, catering truck, lavatory unites, passenger boarding bridges or stair, and only when servicing, loading, or unloading the aircraft. - 5

respiratory alkalosis - high pH, low CO2 pH: 7.35-7.45 acidic-basic HCO3: 21-28 acidic-basic CO2: 45-35 acidic-basic metabolic acidosis - low pH, low HCO3

which crime is often related to alcohol use? - Sexual assault Whose responsibility is it to act as a gatekeeper in regards to the community's ability to obtain alcohol in public establishments? - The alcohol server

which crime is often related to alcohol use? - Sexual assault Whose responsibility is it to act as a gatekeeper in regards to the community's ability to obtain alcohol in public establishments? - The alcohol server

Which crime is often related to alcohol use? - sexual assault Whose responsibility is it to act as gatekeeper in regard to the community's ability to obtain alcohol in public establishments? - the alcohol server

Which neighborhood quality of life issue is most affected by the overuse of alcohol? a. property values b. crime c. traffic congestion d. homelessness - B. Crime