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What are the differences between engagement and managmeent actions? - Answer- Engagement is more emotional, management is more logic based. What is the purpose of the DSP roundtable and how often should they occur? - Answer- To keep DSP informed about company changes; should occur biweekly What contents should be apart of a Stand-up meeting? - Answer- -safety tip -success story -standard work tip -quality tip -volume plan for the day -high level productivity results from previous day ...

Members of IMDRF - Answer- Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, S. Korea, US What types of evaluations are typical variable from nation to nation? - Answer- Performance and clinical evaluations What is the Helsinki Declaration? - Answer- statement of ethical principles for medical research involving humans What are the 5 elements of a conformity assessment? - Answer- 1. QMS 2. PMS 3. Technical doc summary 4. Declaration of conformity 5. Manufacture...

[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - Answer- [A] Agreement meeting [Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product development program to proceed? [A] Type A [B] Type B [C] Type C [D] Type D - Answer- [A] Type A [Q]Which type of meet...

A new chemical isintroduced into a manufacturing facility. The regulatory affizirs practitioner must ensure thatwhich ofthe fOllowing documents are availablefOr the chemical? A DOT manifest B. MSDS e. Interstate Bill of Lading D. USP monograph - Answer- B. MSDS A This document is not usually required by the manufacturer B. B. The information contained in the MSDS must be disseminated as mandated by OSHA regulations 29 CFR 1900.1200 (Hazard Communication) and various state "employee...

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination - Answer- C) You intend to collect blood samples from s...

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 - Answer- B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy and have been published in peer-r...

Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Answer- C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the dev...

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) - Answer- 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) - Answer- D: Kefauver-Harris Amendments Th...

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Answer- C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbrevia...

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 - Answer- ...

CDL Air Brake Endorsement Q&A/DMV Class B License Test: Air Brakes Endorsement/CDL AIR BRAKE ENDORSEMENT QUESTIONS/Florida CDL Airbrake Endorsement/CDL General Knowledge, Passenger Endorsement, Air Brakes Endorsement/Texas CDL - Air Brake Test/CDL (AIR BRAKE ENDORSEMENT) CONNECTICUT QUESTIONS//Commercial Driving test

Optional safety equipment may include emergency phone numbers, tire chains, and: a. Red reflective triangles. b. A charged fire extinguisher. c. Tire changing equipment. - Answer- Tire changing equipment. If the vehicle in front of you is smaller than yours, it can probably: a. Make turns faster than you. b. Outrun you. c. Stop faster than you. - Answer- Stop faster than you. Which of these statements about drinking alcohol is true? a. Statistics show that drivers who have bee...

What will help a drunk sober up? - Answer- Time Do empty truck have the best breaking? - Answer- NO Is it true that as long as the engine is not overheated, it is safe to remove the radiator cap? - Answer- NO Where should you place your warning devises, if you must stop on a one-way or divided highway - Answer- 10 feet, 100 feet, and 200 feet toward approaching traffic Which two special conditions indicate that you should downshift - Answer- Starting on a hill and entering a curve ...

Which of the following is most likely to get stuck on raised railroad crossings? A. A low-slung car carrier. B. A single axle tractor making a return journey empty. C. A single axle tractor pulling a regular trailer. D. An empty moving van. - Answer- A. A low slung car carrier. Is it true that as long as the engine is not over heated it is completely safe to remove the radiator cap? A. Yes as long as there is no overflow. B. Yes as long as the radiator isn't damaged. C. Yes. D. No. -...

A straight truck or bus air brake system should not leak at the rate of more than ______ psi per minute with the engine off and the brakes released. - Answer- 2 Checking your vehicle's suspension does NOT include checking - Answer- a. The shock absorbers b. The air suspension components c. The axle positioning parts d. the tires (correct answer) You have passed all the requirements for a "Class b" bus driver's license. Which of these vehicles are you not license to drive? - An...

A tractor with a(n) ________ trailer requires the shortest amount of stopping distance . 1. empty 2. fully loaded 3. lightly loaded - Answer- fully loaded The air leakage rate for a combination vehicle ( engine off, brakes on) should not be more than _____ psi per minute . 1. 4 2. 6 3. 2 - Answer- 4 If you do not do the final air brake check for air leaks and fix them before driving, 1. you could lose your brakes while driving 2. your fuel usage will increase 3. tire pressure ...

Truck escape ramps: a. Cannot be used by certain types of heavy vehicles. b. Are designed to protect vehicles from damage. c. Should not be used unless you have first tried all other ways to save your vehicle after brake failure. d. All of the above. - Answer- Correct Answer: Are designed to protect vehicles from damage. You are driving a vehicle that could safely be driven at 55 MPH on an open road. But traffic is now heavy, moving at 35 MPH although the speed limit is 55. The safest spe...

How long should the mud flaps on a truck and trailer be? - Answer- Long enough to reach within 8 in of the roadway If you're driving in town, how far will your recommended 12-15 second planning ahead measure in distance? - Answer- about a single block A bridge formula restricts the axle weight for axles which... - Answer- are closer together How soon should oil pressure rise to a normal level after starting the engine? - Answer- within seconds If starting from a standstill on a hill...

You should know that your brakes are fading when - Answer- You have to push harder on the brake pedal to control your speed on a down-grade You must make a very quick stop. You should brake so you - Answer- Stay in a straight line and can steer The brake pedal in an air brake system - Answer- Controls the air pressure applied to put on the brakes The first thing to do when a low air pressure warning comes on is - Answer- Stop and safely park as soon as possible If your vehicle has an...

Air tanks must be drained - Answer- to drain moisture and oil out of the tanks Air braking takes more time than hydraulic braking because air - Answer- Takes more time to flow through the lines than hydraulic fluid. What is the best way to test your vehicle's low air pressure warning signal? - Answer- With the engine off, step on and off the brake pedal to lower the air pressure below 60 psi. The air compressor will stop pumping air into the air tanks at ___ psi - Answer- 125 When s...