If the FDA investigator issues a Form FDA 483 after an inspection, the clinical investigator should:

Answers

Answer 1

Answer:

If the FDA investigator issues FDA form 483 after an inspection, the clinical investigator should respond to the form in writing in less than 15 working days.

Explanation:

The grounds for issuing an FDA 483 form are that there must be some violations of the Food Drug and Cosmetic Act found after the investigation done by the investigators.The management of the firm needs to clarify its stand in less than 15 days on the findings of the investigation that concluded in saying that there are apparent violations of the FD&C Act.

Related Questions

For a sociologist, the goal in examining things such as language, media, and stereotypes is to take what we see as natural and view it as a product of culture. Identify whether the statements support or contradict this goal.

Answers

Answer:

the statement supports the goal

Explanation:

Based on the information provided within the question it can be said that the statement supports the goal. This is because a sociologist must make the familiar things (natural) as strange. This is done in order to uncover the cause-and-effect relationships that exist within these natural occurrences and the society that exhibit them (culture)

Final answer:

Sociologists study language, media, and stereotypes as cultural products rather than natural phenomena. They maintain a neutral perspective and rely on secondary data, media analysis and theories such as dramaturgical analysis to obtain a better understanding of society.

Explanation:

All given statements support the goal of a sociologist to examine things such as language, media, and stereotypes as products of culture, not as natural. Sociologists strive to maintain a neutral viewpoint and study situations for patterns, especially concerning the impact of media and stereotypes. They use different forms of secondary data and media analysis to provide a comprehensive understanding of societal behavior. Furthermore, theory such as dramaturgical analysis by Erving Goffman can be valuable in understanding the roles individuals play in society as well as the influence of their cultural scripts.

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What type of condition describes the situation of the main character of the case below?
Six-year-old Blair liked going to school right up until her first grade teacher, MS. Hanemayer, took maternity leave. The substitute teacher, old Mrs. Snarly, was strict and scolded Blair on several occasions, making her cry. On one Saturday morning as Blair was helping her father with grocery shopping, she rounded the corner and came face to face with old Mrs. Snarly. Blair instantly burst into tears. Blair’s crying at just the sight of Mrs. Snarly is an example of: Select one:


A. A conditioned stimulus.
B. An unconditioned response.
C. An unconditioned stimulus.
D. A conditioned response

Answers

Answer:

A conditioned response

Explanation:

A conditioned response is a response that does not occur naturally but is associated with a neutral stimulus. The behavior is associated that the subject learned is associated with the neutral stimulus. It does not occur self.  

Thu sin the above context six-year-old Blair learned behavior is associated with Mrs. Snarly. When Blair has seen Mrs. Snarly near the grocery store, he started crying because Mrs. Snarly was strict and sometimes she scolded Blair and make him cry. So Blair learned behavior is associated with Mrs. Snarly neutral stimulus.  

Ritual is a practival way for people and communities to deal with the unknown and uncontrollable.
a) true
b) false

Answers

Answer:

a) True

Explanation:

For sociologists, magic rituals serve a great deal of function societies. It is a type of action which prevents individuals and groups not to fall into anxiety and at the same time they acquire the necessary confidence in their abilities. Anxiety may arise when people feel certain desires and do not possess techniques which will ensure them a way to satisfy their desires.

Also, rituals are a determined mode of action. In that reference, myth serves a very important function in the society. Terms like sacred and profane are useful in distinguishing ritual behaviour from other types of action.

which of the following statements is false regarding the findings about gender differences in self esteem during childhood and adolescence

Answers

The false statement was by the middle school years, girls' self-esteem is significantly higher than that of boys.

Self-esteem is how we see and appreciate ourselves. It is founded on our self-perceptions and beliefs, which can be difficult to modify.

Self-esteem is an appealing psychological term since it predicts specific outcomes such as scholastic performance, happiness, marital and relationship satisfaction, and criminal behavior.

According to Hume, it is essential to appreciate and think highly of oneself since it performs a motivating role that allows individuals to reach their greatest potential.

Therefore, the erroneous assertion was that by middle school, girls' self-esteem was much greater than boys'.

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Final answer:

The false statement regarding gender differences in self-esteem suggests a large disparity between boys and girls, whereas research indicates that the averages are quite similar. It highlights that many assumed differences are based on stereotypes rather than empirical evidence. Also, it points out that baseline self-esteem remains stable through adolescence.

Explanation:

The statement that is false regarding the findings about gender differences in self-esteem during childhood and adolescence is that there is a large disparity between boys and girls regarding self-esteem. In contrast, research, particularly by Hyde (2005), shows that while boys have a higher average self-esteem than girls, the average scores are very similar. Additionally, many domains where gender differences are assumed, such as emotions, fearfulness, and talkativeness, are actually based on gender stereotypes and not on empirical evidence. This is supported by large meta-analyses that reveal no significant gender differences in these areas. Although there might be small mean level differences in traits across genders, they are not predictive of individual traits, emphasizing the overlap between genders.

When it comes to self-esteem development, girls tend to have higher self-esteem when engaged in supportive relationships with friends, whereas boys derive self-esteem from their ability to assert independence and influence peers. However, the baseline self-esteem remains highly stable across adolescence, contradicting the popular belief that it significantly drops during this time period.

Alex, the manager at Rues and West Inc., wants to know the sequence of the production process in the company to determine if any process can be combined or eliminated. In this case, a _____ will suit Alex's requirement.

Answers

Answer: Flowchart

Explanation:

Flowchart is the tool that displays flow of process or work. It is represented diagrammatically in the form of step by step manner for displaying particular mechanism or solving a problem. It is linked in orderly manner so that steps can be clearly understood by the viewer for gaining information.

According to the situation mentioned in the question, Alex should use flowchart as per his requirement. He want to know about the process of production in orderly way so he should use flowchart to understand the mechanism step-by step.

Six women were invited to participate in a discussion on motels, hotels, and resorts. A discussion leader first asked them what differentiated motels, hotels, and resort accommodations. Then she asked them to identify all the amenities they expect to find in overnight accommodations. These six women and their group leader participated in an:______a. mall intercept.b. chat room.c. one way communication channel.d. virtual community.e. focus group.

Answers

Answer:

e

Explanation:

Answer:

focus group

Explanation:

In marketing and psychology, a focus group refers to a form of qualitative research in which a group of people are asked about their attitude towards a product, concept, advertisement or idea. Questions are asked in an interactive group setting where participants are free to talk with other group members. The purpose of focus group is to help knowing what the target population thinks of the product, concept or idea in order to make improvements and know what the market consider as valuable on the products.

In this example, six women are invited to participate in a discussion on motels, hotels and resorts. They are first asked what differentiates them and then they are asked to identify all the amenities they expect to find in overnight accomodations. They are being asked about their attitude towards motels, hotels and resorts and questions are asked to them in order to know what they value the most. Therefore, this is an example of focus group.

Charles Darwin's theories prompted other researchers to study all aspects of children's behavior; therefore, Darwin is considered the forefather of ___.

Answers

Answer:    Scientific child study

Explanation:  Scientific children study has first of all started to be applied and is represented as a tool for studying the development of children from birth to maturity. More specifically to study the ways, patterns, regularities and laws by which these developments take place. Since Charles Darwin was dealing with the theory of evolution, his research has encouraged other scientists to deal with children's behaviour. This is because evolution and its principles are closely related to research in the field of genetic behaviour over the life span, that is, development over the life span. In other words, development and behaviour over the life span is conditioned by the genetic material that is inherited, as well as what changes have occurred in the genetic material, the development and adaptation of that material based on the principles of evolution.

Special operations involve the use of small units of specially trained personnel using specialized tactics and equipment to achieve _____ objectives

Answers

Answer:

strategic or operational objectives

Explanation:

Special operations involve the use of small units of specially trained personnel using specialized tactics and equipment to achieve strategic or operational objectives .

In the military, special units are used to achieve strategic and operational objectives.

After her children go away to college, Mary continues to care for her frail parents, but she also starts learning computer programming (which has historically been a male-dominated position) in order to get a part-time job.

Answers

Answer:

androgyny shift

Explanation:

Based on the information provided within the question it can be said that the scenario is illustrating the androgyny shift. In the context of psychology this describes the change that occurs in mid-life, where both men and women retain their gender but begin to inherit traits and qualities associated with the opposite sex.

According to Robert K. Merton, people experience tension when they are exposed to cultural goals that they are unable to obtain because they do not have access to culturally approved means of achieving those goals. Which theory describes this idea?
a. Strain theoryb. Control theoryc. Opportunity theoryd. Differential association theory

Answers

Answer:

The answer is a. Strain theory.

Explanation:

Strain theory explains that individuals are pressured into achieving certain goals, even though they lack the means necessary to do so. The concept is often referred to in criminology, and states that people may engage in criminal behaviours as a result of the strain created by social standards.  

There is a widely held belief that schizophrenia is related to, and may be caused by, excessive activity of the neurotransmitter _____ in the brain.

Answers

Answer:

The correct answer is : Dopamine.

Explanation:

The classical dopamine hypothesis states that the excess of dopamine is one of the main causes of Schizophrenia.

Over the years, scientists have developed certain medications that are currently being used by doctors to treat schizophrenia.

These meds are called antipsychotics.

Antipsychotics prove to be effective while treating certain symptoms of schizophrenia.

All antipsychotics are antagonists of the dopamine receptor, thus they lower the dopamine levels of the patient.

This is why there exists the widely held belief that schizophrenia is related to excessive activity of the neurotransmitter dopamine in the brain.

The phase of Murstein's mate-selection theory that involves dating to see if a potential mate matches one's qualities and traits is called the _____ phase.

Answers

Answer:

value-comparison

Explanation:

The phase of Murstein's mate-selection theory that involves dating to see if a potential mate matches one's qualities and traits is called the value-comparison phase

Which statement best explains how popular sovereignty ensures that the power of the government is limited?
1. Elections allow the people to replace public officials who do not represent what the people want.
2. Dividing responsibility among different branches keeps public officials from becoming corrupt.
3. The explicit enumeration of certain powers prevents Congress from passing certain kinds of laws.
4. Promoting the common welfare requires the different branches of government to work together.

Answers

Answer:

1. Elections allow the people to replace public officials who do not represent what the people want.

Explanation:

The principle of popular sovereignty is based on the idea that the authority of the state and the government remains under the check of the people and is whit consent of the people.The political power is created and sustained only by the support of the people. Popular sovereignty ensures that the power of the government is limited through elections after a given time frame. These elections allow the people to replace public officials who do not represent what the people want or have not performed as per the expectations of the people.

_________ is the distance traveled from the time your brain tells your foot to move from the accelerator until your foot is actually pushing the brake pedal.

Answers

Answer:

Reaction distance

Explanation:

Reaction distance can simply be defined as the distance covered from the moment a hazard is detected to when the driver begins braking or swerving.

In a nutshell, it measures how quick a driver can react to hazards encountered while plying the road.

The reaction distance can be decreased by being aware on the road (increased awareness) and by anticipating hazards. Anticipating hazards makes you relaxed and able to react quickly to sudden hazards.

Final answer:

The distance traveled during the time it takes for a driver to react and begin braking is known as the reaction distance, and it's a component of the overall stopping distance, alongside the braking distance.

Explanation:

The distance traveled from the time your brain tells your foot to move from the accelerator until your foot is actually pushing the brake pedal is known as the reaction distance. This is part of the overall stopping distance, which is the total distance a car travels while the driver reacts and the car comes to a complete stop after braking. It's crucial to understand that this distance consists of two parts: the reaction distance and the braking distance. The reaction distance depends on the driver's reaction time and the speed of the vehicle.

For example, if a car is initially traveling at 50 mph and has a reaction time of 0.500 seconds, you would calculate the reaction distance as follows: First, convert the speed into meters per second since 1 mph is approximately 0.447 m/s. The speed in meters per second would be 50 mph * 0.447 m/s per mph = 22.35 m/s. Then multiply this speed by the reaction time to find the reaction distance: 22.35 m/s * 0.500 s = 11.175 meters. This is the distance the car will travel during the driver's reaction time, before the brakes are even applied.

Understanding the differences between reaction distance and braking distance is important for safety and for analyzing road conditions and their impact on overall stopping distance. Wet pavement, for example, can significantly increase the braking distance, while a prompt reaction can minimize the overall stopping distance.

Research indicates that middle school students who attend ethnically diverse schools feel safer and less lonely than students who attend more ethnically homogenous schools. Which of the following explanations may account for this feeling of safety?

Answers

Answer:

Blame Others for Their Own Prejudices

Explanation:

Ethnically diverse schools contain students from different social and ethnic backgrounds. In such schools, students tend to feel safe since they can transfer blame on other students of different race or religion or color for the mistakes and prejudices they commit.  Students from superior race or culture will easily blame those who come from lower race or culture to hide their misdemeanor.

Chief John Smith is fundraising for his son's hockey team at quarters he invites anyone to:_________

Answers

Answer:

Chief Smith may not fundraise during working hours and he may not solicit his subordinates at any time.

Explanation:

According to the Working Hours Act , the time that an employer pay to the employees shall be used for the behalf of the employer .

Inviting other employees to a hockey match , would be considered as a personal activity and make Chief John Smith became liable of penalty lawsuit from the employer . (the amount of penalty will be depended on the amount of monetary damage that Chief John Smith caused by using his working time for his personal activity.)

Statement B. Chief Smith's actions are appropriate is true.

Chief Smith's actions of inviting people to buy cookies for fundraising are appropriate if he follows organizational policies. It is crucial to ensure that his actions comply with any established rules.

Chief John Smith's actions can be considered appropriate for several reasons:

Timing: Chief Smith is inviting individuals to buy cookies after quarters, which implies that this activity is taking place during a designated break or downtime. It's reasonable for individuals to engage in personal activities, such as fundraising, during breaks or other times when they are not actively performing their official duties.Voluntary Participation: Chief Smith is inviting individuals who are interested in buying cookies to meet him in the office. This indicates that participation in the fundraiser is entirely voluntary and does not involve any form of coercion or pressure. Those who are not interested can simply choose not to participate.Informal Setting: The invitation to buy cookies is being made in an informal setting, namely the office after quarters. This suggests that Chief Smith is not using official channels or resources to conduct the fundraiser, further mitigating concerns about potential policy violations.Community Spirit: Fundraising for his son's hockey team is a common and socially acceptable practice, particularly within close-knit communities such as fire departments. Chief Smith's actions demonstrate a sense of community spirit and support for his son's extracurricular activities.

Overall, Chief Smith's invitation to buy cookies after quarters appears to be a reasonable and appropriate approach to fundraising, as long as it does not interfere with his official duties or violate any specific policies of his department. It allows interested individuals to support a worthy cause in a voluntary and informal manner.

The complete question is:

Chief John Smith is fundraising for his son's hockey team. At quarters, he invites anyone who is interested in buying cookies to meet him in the office after quarters. Which of the following statements is true?

A. Chief Smith is violating fundraising policies

B. Chief Smith's actions are appropriate

C. Fundraising is only allowed off-duty

D. Fundraising should be conducted during work hours

Your friend Susan found her first year of teaching to be very traumatic. She had great difficulty adjusting to the "real world" of school, and she felt overwhelmed by how much she had to learn and to handle.
Which of the following might have helped her most in avoiding such negative experiences during her initial year of teaching?

a) more pedagogy (methods) courses in her teacher preparation program
b) a fifth-year preparation program
c) a mediated entry program
d) periodic, one-day, in-service training workshops

Answers

Answer:

c) a mediated entry program  

Explanation:

                A mediated entry program is short term course program where students can enroll to study. This program is like a crash course and it makes the students prepare well for the further degree or high school degree program. It gives the highlights of the main course so that the student s are well aware of the course in advance as they are prepared well.

               In the context, Susan found the first year of her schooling very difficult and traumatic. She could not handle the course and did not understand what to do. Thus enrolling in a mediate entry program might have helped her to avoid these experiences.

Hence the correct option is (c).

How do more resilient people respond to stress, as opposed to less resilient people

Answers

Final answer:

More resilient people respond better to stress than less resilient people and are healthier, better able to cope, and less depressed. They often have an internal locus of control and engage in problem-focused coping strategies. Physical fitness plays a role too, as regular exercise can reduce stress and protect against stress-related health problems.

Explanation:

Resilient individuals tend to respond better to stress compared to less resilient individuals. They are healthier, better able to cope, and less depressed. Resilient people often have an internal locus of control, meaning they believe they have control over their own lives and can take action to solve problems. They may also engage in problem-focused coping strategies, which involve taking practical steps to address the stressor. Additionally, physically fit individuals are better equipped to handle stress, as regular exercise has been shown to reduce stress and protect against stress-related health problems.

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People perceive vertical and horizontal orientations more easily than other orientations according to the__________.

Answers

Answer:

Oblique effect

Explanation:

People perceive vertical and horizontal orientations more easily than other orientations according to the oblique effect.

Oblique effect is the term used to describe the relative deficiency in perception of other orientations such as oblique orientation compared to the perception of vertical and horizontal orientations.

Final answer:

The ease of perceiving vertical and horizontal orientations is associated with the Gestalt principles of perceptual organization and can be influenced by cultural contexts, such as Western 'carpentered worlds' compared to non-Western environments.

Explanation:

People perceive vertical and horizontal orientations more easily than other orientations according to the Gestalt principles of perceptual organization. In a study by Marshall Segall and colleagues, it was found that individuals' susceptibility to visual illusions such as the M\u00fcller-Lyer illusion varies across different cultures. For example, those in Western cultures, which feature a carpentered world of straight lines and right angles, are more prone to certain illusions than those from cultures with non-rectilinear environmental features, like the Zulu of South Africa with their round huts.

These perceptual differences are influenced by the regular environmental features experienced by people within their cultural context. Such findings underline that basic human perception is not entirely universal but can be shaped by cultural factors, experiences, and the context within which individuals live and grow.

Nonetheless, the principle of pattern perception suggests that while there may be variations in perception globally, there are general processes by which we all discern shapes and figures, and these processes are influenced by our perceptual hypotheses, which are informed by our experiences, expectations, and cultural context.

Stacy Hanes is an African-American woman who has recently taken her first job and does not seem to like the work environment at all. Her colleagues put down her ideas at team meetings and refer to them as "stupid." In addition, they make fun of her race and often ask her if she is educated enough to work for the company. Which of the following kinds of discrimination is Hanes most likely subject to?

Answers

The correct answer is A) mockery.

The other options of the question were B) sexual harassment. C) stalking. D) deception.

The kind of discrimination Hanes is most likely subject to is a mockery.

It is unbelievable that in the 21st century we still have different types of discrimination in the workplace or schools. Hanes is suffering from mockery in the workplace, but there are other types of discrimination due to race, gender, religion, or nationality. If you suffer from any kind of discrimination in school or the workplace, do not hesitate to go inform your boss, your teacher or the internal complain office in your company, that attend these types of aggressions.  

________ is the concept that if a rule is broken, punishment will be meted out immediately.

Answers

Answer:

Immanent Justice

Explanation:

Immanent justice is the concept that if a rule is broken, punishment will be meted out immediately.  This concept was coined by Piaget in his work on the moral judgement of children.

Meredith's baby is 2 weeks overdue. What is a potential hazard that the baby can experience because it is postmature?
a) broken limbs during birth
b) insufficient blood supply from the placenta to the baby’s brain, leading to potential brain damage
c) death or being stillborn
d) lifelong obesity

Answers

The answer is c) death or being stillborn.

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The overall guideline for creating and enforcing zones, building codes, and development requirements is the:_________

Answers

Answer:

Master plan

Explanation:

A  thoroughly-devised master plan is both insightful and convenient....The master plan outlines the concept underlying the desired growth and demonstrates the necessary areas that provide the basis for detailed land use planning and construction as well as land use itself.

A therapist wants to help Hannah recognize her mixed feelings of fear and love for her husband and to realize that she often experienced similar feelings for her brothers during her childhood. The therapist's goal is most clearly consistent with the aims of
(A) psychodynamic therapy
(B) behavior therapy
(C) biomedical therapy
(D) client-centered therapy

Answers

A.bc I looked on quizlet and quizlet it always right

Answer:

a. Psychodynamic therapy

Explanation:

Psychodynamic theory is one of the different approaches used in therapy. This kind of therapy was first introduced by Sigmund Freud. One of the main characteristics of this approach is how it focuses on how our early relationships during childhood determine the way we will relate to others in adulthood. It also focuses in the unconscious patterns that make us repeat patterns of behaviors that we learned when we were kids.

One of the main goals of this therapy is to identify these patterns, understand them and, as the person understand them, a change comes in a natural way and the person can develop healthier patterns of relation.

In this example, Hanna's therapist wants to help her recognize her mixed feelings for her husband and to realize she experienced the same kind of feelings for her brothers during her childhood. We can see that the therapist is focusing in Hanna's childhood and to make her realize how she's repeating patterns she had during her childhood, this is one of the main goals of psychodynamic therapy.

The integrative methodology in the early research of __________ formed the basis of today's developmental approach. Question 1 options:

a) Keith J. Bell and Paul M. Klenowski.
b) Eleanor Glueck and Sheldon Glueck.
c) Rolf Loeber and Marc LeBlanc.
d) Marvin Wolfgang and Terri Moffitt.

Answers

Answer:

B. Eleanor Glueck and Sheldon Glueck

Explanation:

The integrative methodology in the early research of Eleanor Glueck and Sheldon Glueck formed the basis of today's developmental approach.

Storm water runoff from the new development into nearby Samel Creek will likely lead to which of the following?

Answers

Answer:

Destruction of fish habitats by high levels of suspended solids and sediments

Explanation:

Storm water runoff from the new development into nearby Samel Creek will likely lead to destruction of fish habitats by high levels of suspended solids and sediments.

_____ is a two-factor theory stating that for an emotion to occur, there must be

1) physiological arousal and
2) a cognitive interpretation or explanation of the arousal, allowing it to be labeled as a specific emotion.

Answers

Answer:

The answer is the Schachter-Singer theory.

Explanation:

This theory of emotion states that emotions occur because of a physiological stimulus followed by an interpretation of said stimulus.

For example, increased heart rate and sweating may be signs of either excitement or fear. So, after we experience these responses, we must analyse the context and identify how we feel.

If consumption of education creates an external benefit, it means to say that

Answers

Answer:

It means that education must be produced more.

Explanation:

External benefits manifests when a party benefits through the production or consumption of a good. In other words, it is the benefit derived by a party through a transaction, meanwhile, the benefit is not part of the transaction.

External benefits in education include less crime and poverty, political stability and human right will be strengthened.

If you stand on a bathroom scale in an elevator, just as the elevator starts to descend the reading on the scale.

Answers

Answer: The reading on the scale will decrease as the elevator descend.

According to Newton's second law of motion which explains that the rate of change of the momentum of a body is directly proportional to, and in the same direction as, the net force acting on it.

In essence as a body moves towards ground, it weighs less and even weighs more upon impact with the ground.

If peradventure, the whole system is in free fall, you, the elevator and the scale will weigh nothing at all.

Discussion of the legislative department is in Article __ of the Texas Constitution.

Answers

Answer:

Article 3 of the Texas Constitution

Explanation:

Article 3 of the Texas Constitution entrusts the legislative power of the state to two specific branches and they are: the Senate and the House of Representative; and when both of them work together it is the "Legislature of the State of Texas". The Article three also highlights the necessary qualifications that must be attained by representatives and senates and properly provides several regulation to the legislative process.

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