FREEMANSHARP

pathogen disease-producing organism aerobe organism that requires oxygen to live and reproduce anaerobe organism that requires the absence of oxygen to reproduce facultative anaerobe organism that can multiply with or without the presence of oxgen bacteria single-celled microscopic organism exotoxin toxin produced during growth phase of certain bacterua; liberated into medium or tissue endotoxins kind of toxin that can be extracted from a wide var...

1. Determine legitimacy of food borne illness When ________or more cases of foodborne illness caused by the same organism occur during a limited period of time involving either same foodservice operation or the same food product, public health authorities consider it a foodborne illness outbreak. Two A _______ case of botulism is considered an outbreak. Single _________ and ___________ are the two key factors of all outbreak investigations. Speed Accuracy _______ an out...

Food Employee An individual working with unpack aged food , food equipment or utensils , or food contact surfaces Food Processing Plant A commercial operation that manufactures , packages , labels , or stores food for human consumption , and provides food for sale or distribution to other business entities such as food processing plants or food establishments Employee The permit holder , person in charge , food employee person having supervisory or management duties , person on ...

Assemble inspection equipment * Essential equipment - Thermocouple - Alcohol swabs for sanitizing probe thermometers - Chemical test kits - Maximum registering thermometer - Flashlight - Head cover, such as hair net or baseball cap Calibrate food safety equipment Ice water 32F Boiling water 212F Schedule the inspection When food is being prepared or served and staff is present Timing that can evaluate receiving, preparation, and cooling Evaluate HACCP programs .....

A fish toxin originating from histamine-producing bacteria is Scombrotoxin A foodborne illness is classified as intoxication when ______. A toxin is produced by bacteria on or in the food prior to ingesting it A chemical is present in the food or drink prior to consumption Aerobic bacteria are organisms that can survive and grow in an oxygenated environment, and anaerobic bacteria are organisms that do not require oxygen for growth. True A toxin found in seafood that ...

What should be on a pesticide besides the manufacturer label? 1. Common name. 2. Chemical name. 3. Sanitation methods. 4. Date used. 1 Prepared food is stored for cooling. Which of the following is true? 1. It must be wrapped. 2. It must be kept dry. 3. It must be stored in liquid. 4. It does not have to be wrapped. 4 Foods typically need to be wrapped for storage. Prepared food does not have to be wrapped for a cooling process. (B) When placed in cooling or cold holding EQUIP...

What occurs when a pathogen grows within the body? 1. Food intoxication. 2. Fungal contamination. 3. Parasite. 4. Food infection. 4 Food infection and food intoxication develop in different ways. Food infection occurs when the pathogen develops within the body. Hepatitis A is an example of an infection. An employee has nasal discharge. What is the appropriate response? 1. Exclude the employee from the premises. 2. Send the employee to the doctor. 3. Monitor the employee to make s...

CP-FS Flash Cards 2023

Four phases of bacterial presence in food 1. Lag Phase, 2. Log Phase, 3. Stationary Phase, 4. Death Phase Log phase Most essential phase of bacterial presence in food due to the fastest increase in populations Lag phase Time/temp play an important role in keeping bacteria in this phase (where numbers are less dangerous and growth is slowed) Norwalk virus Rarely a pathogen associated with shellfish Hepatitis A virus (HAV) and Vibrio spp (a bacteria) 2 common patho...

The vegetable provider needs to have which of the following? 1. FDA. 2. GAP. 3. Grade A. 4. GMP. 2 Good Agricultural Practices (GAP) are necessary from a vendor. How long can you take to cool hot food according to the Food Code? 1. 4 hours. 2. 8 hours. 3. 6 hours. 4. 12 hours. 3 135F to 70F in 2 hours 135F to 41F total 6 hours What needs to be removed from a room before it is treated for pests? 1. Food. 2. Flooring. 3. Equipment. 4. Food and equipment. 4 It is im...

Inundated same flooded fragile same delicate unique same unparalleled elimination same removal imminent same soon proficient same skilled ostentatious same pretentious intangible same indefinable outmoded same obsolete integrity same honesty abnormal same unusual overt same open panacea same cure glib same superficial nondescript same undistinguished spiteful same malicious ...

510(k) Clearance A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manufacturer may market it immediately. Humanitarian Device Exemption (HDE) Holder The HDE Holder is the entity that obtains the approval of a HDE from the FDA and may be a manufacturer, sponsor, firm, or an...

Which of the following lists the three principles included in the Belmont Report? Respect for Persons, Beneficence, Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of informed consent as described in the Belmont Report? Information, comprehension, voluntariness. Module 2 ....

Q 1 Good Clinical Practices (GCP) is an international, ethical, and scientific quality standard for conducting, documenting, and reporting human trials to provide assurance that the rights, safety, and well being of trial subjects are protected. Where are GCP regulations/guidance found in? ICH E6 21 CFR part 56 21 CFR part 50 21 CFR part 46 NOT 21 CFR part 96 What is one of the principles GCP according to of ICH (international conference on Harmonization) guiedlines? - Records m...

What are Good Clinical Practices (GCPs) A standard by which clinical trials are designed, conducted, recorded, and reported so that there is public assurance that the data are credible, and that the rights, welfare, safety and well-being of subjects are protected International Conference on Harmonization (ICH) - Brings together the regulatory authorities of Europe, Japan, and the United States - Includes Experts from the pharmaceutical industry - Discuss scientific and technical ...

CH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that "the monitor(s), the auditor(s), the IRB/IEC, ...

A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development. b. Minimize the need for redundant research The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the design, conduct, monitoring and reporting of clinical research. c. G...

You overhear someone say the following about Good Clinical Practice (GCP) in the hallway: "GCP is mostly just meant to curb abuses by unscrupulous researchers who make bad decisions in response to pressure to discover the next big thing." What could you say in response to this? - a. That's right; GCP are very rigorous rules that every researcher must follow - b. That's not quite right, because GCP is really more about the behavior of participants...NOT about the behavior of researchers - ...

good clinical practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. GCP Objective provide a unified standard for the european union, japan, and US to facilitate the mutual acceptance of clinical data by the regulatory authorities of t...

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). a. principal investigator b. sub-investigator c. study coordinator d. coordinating investigator b. sub-investigator Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitaliz...