Idealistic vs. materialistic motivation Essay

Both the Americans and the British fought in a more open order with more significant gaps than was the norm in Europe because the general absence of cavalry made the infantry less vulnerable to attack, while the enclosed nature of much of the terrain encouraged deployments that reflected the topography. Heavily-encumbered regular units, maneuvering and fighting in their accustomed formations, were vulnerable in the face of entrenched positions and unsuited to the heavily wooded and hilly terrain of the Canadian frontier; they were also not ideal for the vast expanses of the South. Artillery and fortifications played a smaller role than in conflict in Western Europe. Compared to the armies of Frederick the Great, both the American s and their opponents were lightly gunned. The Americans did not inherit a significant artillery park, while, for both sides, the distances of America and the nature of communications discouraged a reliance on cannon; they were relatively slow to move. As a result, although cannon played a role in battles such as Monmouth Court House, battles were not characterized by the efficient exchanges of concentrated and sustained artillery fire seen in Europe. This benefited the Americans as the British had greater access to artillery, and had used it with considerable success in European campaigns in the Seven Year’s War (French and Indian War). The motivation was more materialistic. We were actually able to unify and motivate these groups even through their separate motivators were so different. But they weren’t mutually exclusive. Today in the United States, we have two kinds of motivators going on at an indigenous level: one is a unification of the population against terrorism, and the other is the preservation of the â€Å"American way. † What we’re trying to motivate ourselves to do – as the nation focuses on the preservation of the American way – is to preserve democracy and the free enterprise system. This two-rack motivator encompasses the right to be free from fear on a daily basis and the right not to have your property destroyed by an enemy force. References: Black, J. (2002). America As a Military Power: From the American Revolution to the Civil War. New York: Praeger/Greenwood.

Grace of God Essay

The traditional social order is marked by the three estates it comprised off. The ruler who is supposed to be ‘by the Grace of God’ was absolute in his power. The first estate comprised of the clergy who were responsible for community well being by conducting prayers and sacred ceremonies. The next estate is the nobility who are in charge of protecting the country from foreign invasions. They also played an important role in government and in administration. The third estate consisted of the majority of population. They generated wealth that fed the entire society. Real estate and regional commerce were their main activity. This order underwent change at the wake many significant events. The French revolution gave power to the bourgeois, the third order. The French viewed democracy as a building block of creating a new social order where there is no self proclaimed monarchy hovering over. The spirit of French revolution spread across Europe. And slowly the rising started everywhere. The colonized countries started gaining grounds in their home lands. The Sepoy Mutiny in India is an example of the social order undergoing a change. The natives organized an uprising against the British. It may not have deterred the British in their pursuit to expand but it did mark an important turn of events. Similarly the West had its influence on Japan and China. The monarchy and the aristocracy slowly started to adopt the ways of the West. Starting from their dressing to their way of life, a significant transformation was taking place. The Crimean War,1853-1856 Describe the causes, course, and consequences of the Crimean War and evaluate the effect of the war on Russia’s government. One of the main causes of the Crimean War is the misperceptions in Russia, Britain and France. Britain and France were disturbed that Russia was the strongest state in Europe and its assumed Russian expansion plans towards Turkey. On the other hand Russia was cautious of revolutionary France. Russia was also expecting the fall of Turkey. Moreover in the holy place of Palestine the Catholics were favored by France and the orthodox Christians were favored by Russia. The Catholic and Orthodox monks disputed possession of the Church of the Nativity in Bethlehem and the Church of the Holy Sepulchre in Jerusalem. During the early 1850s, the two sides made demands which the Sultan of Turkey could not possibly satisfy simultaneously. To solve this issue the Tsar of Russia, Nicholas I sent his diplomat for talks which failed. The demands made by the Tsar were rejected. Austria contrary to what Russia believed sided Britain. Further in an attempt to revert war a four point proposal was presented to the Tsar. When the Tsar refused to comply with the four points, the Crimean War commenced. The reality of the war is that France and Russia injured each other’s options without knowing they did so. France overestimated Russia’s hostility and Russia underestimated British and French interest in Turkey. As a result, Russia seeking to secure Black Sea region lost its control until 1871. Russian power in the area declined to be restored only after fourteen years. During peace negotiations in 1986, it was decided that no warship would occupy the Black sea coast. This became a specific disadvantage to Russia as it diminished the naval threat it posed to the Turks. Compare and contrast China’s and Japan’s response to western influence for the period of 1850 to 1865. In the 1800s China and Japan experienced both major internal strains and Western imperialist pressure which was backed by military might which the natives couldnot match. China’s leading position in the world reversed in a mere 100 year period (c. a. 1840-1940) from leading civilization to subjected and torn country. The Japanese witnessed China’s experience with the military power of Western nations. At the arrival of an American delegation in Japan in 1853, Japan was also forced to open its ports to the Americans. But unlike China, Japan was able to adapt rapidly to match the power of the West and soon established itself as a competitor with the Western powers for colonial rights in Asia. In 1894-5, Japan challenged and defeated China in a war over influence in Korea. This upset the traditional international order in East Asia, where China was the supreme power and Japan was a subordinate power. Western nations utilized China for their opium trade. They took silver bullions from China as commodity exchange. China’s attempt to ban the sale of opium in the port city of Canton leads to the Opium War of 1839. The Chinese were defeated by the British arms. This lead to China opening up its ports for foreign trade. By 1800 China was in a vulnerable position in the hands of the West. From the 1860s onward, the Chinese attempted to reform efforts to meet the military and political challenge of the West. China adopted Western learning and technology while preserving Chinese values and Chinese learning. Reformers and conservatives struggled to find the right formula to make China strong enough to protect itself against foreign pressure. The Japanese taking the cue from China launched a major modernization effort in 1868 to match the West and then came to be a major competitor for rights. Japan’s defeat of Russia, a Western power, in the Russo-Japanese War of 1904-05 surprised China. This way the West influenced two the countries in its most significant way.

Recruitment Essay Example | Topics and Well Written Essays - 1500 words

Recruitment - Essay Example The labor market conditions determine a number a factors that will affect our recruitment plan. The demand and supply of labor will determine the market mechanism. The equilibrium of the demand and supply of labor will determine the wages or salaries. Besides this, other factors that could affect our recruitment plan include government regulations in the market. These regulations could be a minimum wage set by the government or could also be other regulations regarding the number of employees that can be employed etc. According to research carried out by the Human resource department of Eatwell, the skilled labor present in the region we plan on opening our next branch does not belong to any sort of trade unions. This is an advantage for us because no trade union means that the labor will not be strong enough to influence our decisions. However, a throughout England, there is a minimum wage law set by the government and we will have to consider this before deciding on wages for our u nskilled labor. Secondly, since there are not many superstores in the area where the new branch is being opened, we have many opportunities that we can make use of. The labor over there does not have much choice, giving us an advantage of excess labor supply. This will allow us to choose the best possible employees for Eatwell from a wide range of labor supply. In order to calculate the number of vacant jobs in our new superstore, we will need to consider a number of aspects. First of all, we will consider the number of employees in the other branches and compare it with the branch's size. This will give us an estimate of the amount of vacancies available for our new branch. Then we will consult various departments and ask them their requirements of employees. These requirements will also be considered and formal job descriptions will be developed for each job identified. These job descriptions will be useful later on in the recruitment process when the jobs will be advertised. Another aspect that needs to be considered is hiring the number of recruits which will most profitable for the firm. Too many employees hired could result in diseconomies of scales while fewer employees than required mean lower output. This is how the exact number of available jobs will be identified and employees will be recruited accordingly. In order to be efficient, a firm needs to be flexible. Atkinson gave a flexible firm model in 1984 according to which flexibility in an organization depends on workers of two kinds, the core workforce and peripheral workforce. The core workforce consists of those employees that are regular and permanent. The organization has a standard contract with them. On the other hand, the peripheral workforce consists of those workers which are semi-permanent. They are hired when they are required and fired when the work is done. They are also called just-in-time workforce and disposable workforce. The peripheral workforce is actually what makes a firm flexible. The firm can hire a worker whenever the need arises and dismiss him as soon as there is no more need. This model will give Eatwell a competitive advantage over rest of the supermarkets in the market. This practice allows a firm's average cost to decrease and the efficiency to increase. This model can be applied to our recruitment plan a s well. All the low paid and low skills jobs will be included in the peripheral wo

Art for Individual And Social Changes Essay Example | Topics and Well Written Essays - 1000 words

Art for Individual And Social Changes - Essay Example Her exhibit showcased portraits from each of these women. They allowed themselves to be vulnerable, so that they can share their experiences and lessons with the world. The main argument of the article is that art can be used to promote individual and social changes through accepting one’s vulnerabilities, while having hope in life’s possibilities. This paper analyzes the rhetorical strategies used to assert this primary argument, specifically repetition, emotional appeals, and anecdotes, which are effective in illustrating the transformational power of homelessness, and using art to be released from its financial and psychological trauma. Before this paper proceeds to analyzing the rhetorical strategies of this article, the premises of the article will be examined first. The stated premises are: art provides deeper self-understanding; art presents universal meanings that people from different backgrounds can relate to; and more artists should engage in activist art, in order for them to address contemporary social and political issues using their talents. The implicit premises are: 1) art is the language of the human soul and 2) even those in the margins have a capacity for making art and making sense out of art. In essence, even the poor have art in their hearts. These premises are relayed to the rhetorical strategies used in the article. ... ough† and â€Å"poor† are repeated twice in this statement, as well as the word â€Å"African American.† This statement effectively shows that minority groups have rougher lives than the white population, because there are fewer economic and social opportunities for them. Because of these rough lives, they can also easily slide back to poverty, even when they have escaped it earlier in life. For instance, many of these women in the article, when they lost their jobs, husbands, or homes, declined from middle class status to lower class. The older they get, the more vulnerable they are, because society views the old as dispensable beings. As a result, an old African American woman is exposed to the greatest risk of being homeless and poor. This article also made successful employment of emotional appeals, without sounding naive or sentimental, and instead, they underscore the universal feelings, dreams, and fears of people, whatever their race, age, gender, and soci al class might be. Fulmer discloses how these women’s art will also emotionally affect her: â€Å"The act of creating the artwork meant permitting myself to feeling vulnerable to their experiences that may hurt, twist, turn, and otherwise impact my own personal psyche.† She is saying that when these women become vulnerable, she becomes vulnerable too. They open their hearts, which opens hers in the process. When they go back to the past and remember their pain and suffering, Fulmer cannot help but identify with them, not because she has been homeless before, but because at different points in their lives, people also experience the same hopelessness and loneliness that homeless people feel. In addition, Fulmer also reflects on her writing, which helps her cope with the emotional engagement she feels with this

How does new technology help the Arts Essay Example | Topics and Well Written Essays - 2500 words

How does new technology help the Arts - Essay Example As a result, interactions between artists and technologists determined the impact of the computer (digital) technology on creative process. Today many artists and digital media specialists agree that technology helps the arts. They point out at the context of the digital society we now live in and how it influences the ways the art gets created, marketed, produced, supported, preserved, distributed, as well as transformed. This paper explores how new technology and digital media help the arts. Objectives The objectives of this research paper were as follows: Provide an overview of contemporary knowledge on the topic of the impact of technology on the arts and on the topic of how technology helps the arts. Determine how new technologies affect the arts in a positive way The paper was intended to provide response to the following question: What positive impacts and what opportunities has technology created/ is creating for the arts, artists, the public, etc? Approach and Methodology It was determined to focus the paper on modern, in particular digital technologies and shape the scope of the research with emphasis on the arts. It was reinforced that the paper should provide information with reference to various arts, various art disciplines, and various art practices if possible. Also, it was reinforced that the research should concentrate on how technology influences creation, production and different ways in which artworks reach the general public. Throughout the research, the author reviewed English-language material and researched publicly-released data from UK and international sources; synthesized information. B. ARTS AND TECHNOLOGIES: LOGICS OF HYBRIDIZATION The hybridization of technology and the arts, as it has been assumed in modern studies, began in the 15th century with the invention of printing and distribution. Connection of the literary tradition with distributive power of the printing technology changed the whole European civilization. The value of cultural hybridization as the fundamental logic of cultural change has been convincingly demonstrated in the research by Marshall McLuhan (McLuhan, 1962; McLuhan, 2001). In particular, using an example of the distribution of the press, McLuhan demonstrates the decisive role of this technology in the cultural dynamics of the period between the 15t and 19th centuries. In the scholarly terminology, the printing technology may be described as the first level of the hybrid of technology and art. In its essence, the printing technology does not define the aesthetic content of art work distribution, yet its use can well have an impact on the artistic content which is being distributed (here: the literature in its broadest meaning), transforming the form of distribution in purely independent art (for example, graphic design, fonts). It may then stimulate the expansion of the variety of literary forms, available in printed format. In addition, the advent of printing marked a fundamental shi ft from the ancient ‘techno’ and technology - which were about the finesse and skill of a human working with his hand to deliver the product of creativity - to technology which became the logics of self-alienated production. This way it may well be thought to be a harbinger of the machine age (Benjamin, 2008). At the end of the 19th - at the beginning of the 20th century art’s hybridization with technology shifted to a new level in the aesthetics of cinema. Cinema evolved as a

Motivation in a Multigenerational Radiologic Science Workplace Research Paper - 1

Motivation in a Multigenerational Radiologic Science Workplace - Research Paper Example This paper illustrates that organizational behavior has changed tremendously since the industrial revolution, and so have the ways for employee motivation.   Since the inception of management-related studies, the area of employee motivation has been emphasized in various ways. This discourse presents a brief review of motivation factors for radiological sciences workforce based on a specific study conducted by Kalar. Earlier, classical management theories proposed employee motivation practices such as incentives and bonuses.   The pioneer of scientific management, Fredrick Taylor asserted that the main aim of management should be to secure maximum prosperity for the employer, coupled with the maximum prosperity for the employee. Taylor believed that extra income will motivate employees to work extra and with greater efficiency, and hence incentives would be an effective way to motivate the employees. Later, the human relations movement led by Hawthorne experiments of Elton Mayo p roved that employee motivation can be enhanced through employee participation and involvement with the leadership teams. From a motivation perspective, numerous theories can be found, in the literature that describes various motivating factors and ways to motivate. A few of these theories include the Maslow’s needs theory, Alderfer’s ERG Theory, Herzberg’s two-factor theory or the motivation-hygiene theory, McClelland’s 3-needs Theory, Vroom’s expectancy theory etc.  

STRATEGIC DECISION MAKING IN SAUDI ARABIA HIGHER EDUCATION SECTOR IN Literature review

STRATEGIC DECISION MAKING IN SAUDI ARABIA HIGHER EDUCATION SECTOR IN GLOBAL CONTEXT - Literature review Example University decision-making processes are influenced by political, economic, cultural as well as technological factors (Elyas, & Picard, 2013, p. 31-41). The factors affect literally all aspects of the operations of universities and are global in nature. They therefore influence on the environment within which the universities operate, the expectations of the public in services to be offered in the future as well as the structure and sources of funds necessary for their management and running. Decision making process involves making conscious choices among many alternatives and requires critical thinking as well as sound reasoning in order to choose on the most appropriate alternative among the many (Rugh, 2002, p. 45-50). Strategic decision making therefore entails a number of attributes, which include definition, and identification of a problem, identification as well as analysis of alternatives, choosing and implementing an option as well as evaluation on the outcomes from the choi ce made for possible corrections. Besides, it is noted that decision-making and management of higher education in Saudi Arabia is not free from government influence (Onsman, 2011, p. 519). The higher education sector in Saudi have undergone through great structural and ideological change especially after the 9/11 global policy shift feature. To substantiate this, Elyas and Picard carried a study in critique of the system of higher education sector in Saudi while in perspective with global context (2013, p. 31-41). In among other findings, the effect of western economies (neoleberalism) was shown to have greatly influenced the system. Both learners as well as top management teams have embraced the policy paradigm shift in globalization as well as neoliberalism. However, in a critical view, authors have argued that adoption of ‘localized’ neoliberalism would be more effective in shaping the environment of

Family Business Research Paper Example | Topics and Well Written Essays - 1000 words - 1

Family Business - Research Paper Example This can foster a feeling of resentment among family members who are not qualified enough to do the necessary work, but share the name of the company’s founder. In such cases, the heads of family-run organizations have to deal with the uneasiness of other family members at the thought of hiring outsiders to be privy to the long-held family secrets. According to a survey conducted by PricewaterhouseCoopers to determine how family-run businesses achieve success, a number of the heads of such corporations choose not to involve extended family members in the making o important decisions even if the said members are considered as part-owners. In this survey, 15% of the surveyed family business leaders said that relatives such as in-laws do not have to be involved in decision-making (Miller and Le Breton-Miller 38). In a different survey conducted by the Egon Zehnder International organization among 720 family business executives and owners from Asia-Pacific, the Americas and Europe , over 60% of business managers felt that the lack of professional procedures and administrative structures is the biggest shortcoming of family-run businesses (Brun de Pontet and Aronoff 45). In addition, 55% of executives surveyed indicated that divergences among family members, due to a lack of accountability are another big problem. 60% of the respondents in this survey confirmed that family quarrels often get in the way of making good business decisions such as hiring external experts to deal with recurring problems (Brun de Pontet and Aronoff 46). From these two surveys, it appears that family conflict can result in the wrong decision being made due to the absence of an objective perspective. According to the KPMG and Family Business Australia’s biennial survey, which was conducted with 658 family-run businesses based in Australia, 57% of participants indicated that as family business leaders, they were concerned about the intentions of their potential successors, wheth er their children, or other relatives. In addition, 63% of the polled family business leaders indicated that they were not impressed by the abilities of their potential successors (KPMG and Family Business Australia Survey of Family Businesses 3). This corresponds with the findings of the Egon Zehnder International organization survey which also established that 60 % of the family business leaders had doubts about the proficiency of family members. According to these leaders, this was a common cause of conflicts among the family members (Brun de Pontet and Aronoff 46). It would seem that the biggest problem that family business leaders have to grapple with is the refusal of family members to accept the fact that they may not have the necessary skills to function in specialized operations. This can be a particularly difficult problem to solve because any skilled outsiders who are hired are likely to be met with hostility and subversive acts from disgruntled family members. Another pr oblem often faced by family business leaders has to do with making decision on strategic planning. Today, the family that is successful in progressing at a steady rise from generation to

Issues Related to Social Security Fund Essay Example | Topics and Well Written Essays - 1000 words

Issues Related to Social Security Fund - Essay Example In 2012 balance of payment in the fund was 57.3 Billion dollars on the plus side after paying complete liabilities which shows good situation of the fund. However 2012 Trustees Report has projected calculations according to which the fund will collapse by year 2033 due to downward trend in wages and excessive borrowing by Treasury. There have been speculations by financial experts according to which the fund lacks strength to sustain itself over coming decades despite current value of $ 2.7 Trillion quoted by National Committee to Preserve Social Security and Medicare ( 2012 ) . According to There is one opinion that it is unfair to charge the same amount from a billionaire and the one earning $110,000 per annum . The fixation of earning limit is known as Payroll Cap, which is required to be enhanced to $ 250,000 to keep it progressive for the next 75 years, according to few analysts. According to senator Bernie Sanders quoted by Common Dreams Website (2012) â€Å"Social Security Fu nd faces no risk†. Currently 55 Million American benefit from the fund. Although the income may be as low as $ 23000 for a couple, in many cases this is the only source of income they have in the old age. In this back drop the fund is saving millions from poverty in old age and remains one of the best social programs in American history. The significance of program can be judged from the fact that before it half of senior citizens lived under poverty whereas after its launch only 10 % live under that line. The current discussion about the program is related to budget deficit in USA. Few financial experts have proposed that in order to balance the budget a cut should be introduced on social security fund and other programs like Medicare and Medicaid etc. President Bush introduced tax cuts for two years in 2010 which will expire in the end 2012. There is a debate that these tax cuts be made permanent despite the fact that over next 75 years loss in revenue due to taxation would be twice as great as shortfall in social security fund. For long-term solvency in Social Security Fund an early decision by lawmakers is necessary to spread cost over decades and give savings confidence to people retiring over the years. The budgetary cuts imposed now will have economic impact on American Nation in the decades to come therefore extreme caution is required while making changes in legislation. People who were born in baby boomer era would be entering retirement bracket in current decade therefore there would be a bigger pressure on Social security Fund. However it is upto the policy makers to guide the Nation in the correct direction. Why was the article written about the topic at the current time? The article has been written at the current time due to following reasons. First of all Bush Administration enacted the Taxation laws in end 2010 for two years, the limit of this law would have terminated by end of 2012 however it has been extended by President Obama accord ing to Jennifer (2012) . This means payment of more taxes in the name of Social Security and other related programs. Since Social Security Fund is already surplus to the tone of $ 57.3 Billion after paying liabilities, there has been a demand to slash down the fund. Historically it is common for this fund to exceed liabilities therefore reduction in this fund to balance the budget (due to recession) is being demanded which is not logical in the long term effects on dependents of fund. How

Kano Model Analysis Research Paper Example | Topics and Well Written Essays - 2500 words

Kano Model Analysis - Research Paper Example The major drive has been â€Å"forces of globalization†, which have contributed towards a heightened awareness of the opportunities available for education globally (Morady & Siriner, 2011, p.35). In this sense, Institutions must remain aware of the issues that influence consumer choice of institutions of higher learning because there is a lot of competition for educational services. This is the reason why it is important to research the issues that influence the degree of satisfaction of students, who are the primary consumers of educational services, in the institutions. Structure of the Report This report carries a section that considers theories relevant to the study. It gives way to a discussion of the research method used in this project, its benefits and limitations. The next section concentrates on the findings of the project, which pave way for the concluding remarks, which include a set of recommendations. Chapter I - Theory The study of consumer satisfaction falls i n the same general academic field that includes behavioural sciences, human psychology and consumer sciences. As with many other academic disciplines, there is no consensus on a single definition of consumer satisfaction. Giese and Cote (2002) summarized three basic areas that most of the definitions of consumer satisfaction cover as follows, 1) Consumer satisfaction is a response (emotional or cognitive); 2) the response pertains to a particular focus (expectations, product, consumption experience, etc.); and 3) the response occurs at a particular time (after consumption, after choice, based on accumulated experience, etc) (p.1). This summary sufficed for the needs of this research project because it captured the issues that the project sought to... The study pave way for the following conclusions which aim at providing the managers of institutions of higher learning with the information they need to improve customer satisfaction in their premises. The paper also makes appropriate recommendations: 1. Students value good lighting in their lecture rooms hence the management should always ensure that buildings incorporate natural lighting. This will increase customer satisfaction in the facilities. 2. Management must resist the urge to increase the number of students in the classes because there is a significant association of comfortable sitting space with a satisfying experience in the lecture halls. 3. Apart from the necessary equipment for air conditioning, there is diminishing value in investing in sophisticated temperature control equipment. The perceived value of comfortable temperature diminishes soon after the environment is comfortable. In this sense, institutional managers should not spend anything more than is necessary for temperature control. 4. Background music does not add much value to the overall satisfaction of students. Institutions should therefore avoid investing in this service because it is not worth it. This research project focused on the conditions of the buildings and lecture halls. Therefore, it is incomplete as a measure of the overall satisfaction of students in higher education institutions. There is need for further research that will capture the indices relating to social services and service delivery to capture the full spectrum of issues that affect the satisfaction of students in the institutions of higher learning.

The Impacts of Oil Spills on Marine and Terrestrial Ecosystems Essay Example for Free

The Impacts of Oil Spills on Marine and Terrestrial Ecosystems Essay Buy custom Impacts of Oil Spills on Marine and Terrestrial Ecosystems essay In this paper am going to examine the factors contributing to oil spills, and their effects on marine and terrestrial ecosystems. This addition of phytoplankton leads to depletion of oxygen levels in water, making it hard for survival of animal and plant population in the water. These oil spills do not only affect the marine system but also the chronic urban contamination and the economic loss. The oil spill has total effect on marine life despite the distance from the oil spill. The closer the oil spill is to the shoreline, the more damage it causes. The effects are also felt toward the offshore and the coastal environment. Oil spill is an accidental or intentional release of liquid petroleum hydrocarbon into the environment. The environment is onshore or offshore leading to pollution. Mostly the key pathway of oil spills is through the marine oil spills. In this pathway, oil is released into the aquatic environment. The process is through spills from tankers drilling rigs and wells. Naturally oil may enter the marine life through oil seeps. The effects of oil spills are in many cases long-term effects. The short-term effects, though, can also be disastrous. Oil spills are dependant on wind and currents for faster spreading. When oil mixes with the water, it forms a sticky substance known as mousse. This substance clings to whatever it comes into contact with since it is sticky. Some marine animals mistake it for food. Birds usually have a hard time flying after coming into contact with the mousse. The mousse makes the birds’ feather heavier, making it impossible for the bird to fly thus drowning. The bird also becomes vulnerable to predators since it cannot fly. Predators that feed on these dead birds also end up dying due to poisoning by the mousse (McCoy Salerno, 2010). The oil enters into the plumage structure of the bird and reduces the insulation capability. The bird is thus exposed to temperature fluctuations and less buoyant in water. The birds ingest the oil on the feathers, and this causes kidney damage and malfunction of the liver. A very small percent of birds exposed to oil spills survives unless there is an intervention by a human (Peter Smithson, 2002). The marine mammals that are largely affected by oil spills consists of the Seals, sea lions, polar bears, sea otters, whales, dolphins, and manatees. This is due to their adaptation main power in fur and blubber. The mammals living in a cold environment are mostly affected by hypothermia. Other effects include organ malfunction due to toxic exposure. The organ malfunction consists of interstitial emphysema gastrointestinal ulceration. The mammals encounter a lot of stress due to restriction of diet and continuous exposure to oil. Seals are highly vulnerable to oil spills since they spend much of their feeding time near the surface of the water. Fur seals are exposed to oil adhering to the fur. The adhering leads to the fur loosing insulation ability. The oil coating on fur seals results also in reduction in swimming ability and a lowered mobility of the seals on land. The seals are also affected by poisoning caused by feeding on already contaminated prey and inhalation of oil droplets. Sea otters usually spend their time on the water surface and are totally dependant on fur for isolation and float ability. The famous Exxon Valdez disaster is blamed to be the main cause of 15,000 otters, due to ingestion of oil. Polar bears depend on blubber and a thick under fur for insulation. They often groom their fur. While grooming oil contaminated fur, polar bears may swallow oil, resulting to death due to intoxication. The intoxication damages the kidney and lowers the ability to produce red blood cells in polar bears. Whales are rarely affected by oil spills as they are always on migration. Baleen whales are the only whales affected as oil stick to the whales when they are filtering their feed. They take a large amount of water in order to select their catch. A dolphin is a smooth-skinned and hairless mammal. Therefore, there is less possibility of oil sticking to their skins. In this case, the dolphins are affected by the inhalation of oil vapor. The inhalation damages the dolphins’ airways and lungs. The other minor effect is the dolphins’ eyesight and unending stress. Manatees and dugong are found in areas with warm waters; also depend on a layer of blubber for insulation. Their effect by oil spills is similar to that of the dolphins. Oil spills damages the turtle airways when they surface on top of water contaminated by oil slick. Their feed is affected also affected by oil spills and thus poisons the turtles. The areas that the turtles nest in the beaches are sandy. Oil contamination on the nesting sites leads to contamination of the eggs inhibiting proper development. Fish, one of the largest populations in the marine life ingest oil through their gills. This ingestion often leads to enlargement of the liver and reproduction capacity. In the Gulf of Mexico, there is an alarming rate at which the fish are dying due to the effect of oil spills and contamination. The death of fish is due to skin lesions, fin rot and liver blood clots in the fish surrounding the environment (Margaret Judith, 2010). The only effect on shellfish is not direct. The effect is indirect, since the affected is the person feeding on the shellfish. Shellfish exposure to oil spills leads them to acquiring an extremely unpleasant taste and makes it impossible to be eaten. The effects of oil spills on plants vary with every species of plant. The most common effect in all the species is the coating effect. This is because almost all plants depend on their leaves for production of food. The coating of oil on the leaves makes it impossible for the plant to have proper exchange of gas with the environment and production of food. This effect leads to slower growth rate of plants and in some cases quick death of the plant. Oil spills contamination leads to the death of algae and plankton. The large number of plants dying leads to excessive addition of ammonia and nitrites in the water. Conversely, levels of dissolved oxygen lower just as the pH levels. The changes in water chemical composition lead to toxicity of environment as a whole. Oil spills contribute in extremely large portion of polluting the environment. Proper measure should be put in place to avoid such mess. The measure accounts from government policies proper and self-regulatory measures per each person. This can be achieved through proper education of the society on the dangers of oil spill pollution and strict government policy to ensure that person complies. The hotel industry should also be cautious with the type of sea food that they sell. Proper Seafood Sensory Training is recommended for them to enable them detect oil in seafood. Float oil barriers should be used around the affected area, especially the ones with strong currents. Any incidence of oil spillage leads to possible death of either the marine animal or plants. Therefore, the source of this pollution should be dealt with as it may take many years to clean the effect.

The Issues Surrounding Disability Social Work Essay

The Issues Surrounding Disability Social Work Essay There is a lot of discussion of how disability is described. The literal meaning of disability is difficulty with ability. This implies some form of mental or physical impairment that can manifest problems with mobility or awareness. According to the Disability Discrimination Act 1995, disability impairments can include sensory impairments such as hearing or sight, mental impairments such as depression or learning difficulties and physical impairments such as wheelchair users. People with disabilities may face problems, and not only because of their particular impairments but by social factors such as attitudes, stigma and physical obstructions, for example, ease of access to buildings or transport. The description of disability has varied over the years but the Disability Discrimination Act 1995 describes it as, he/she has a physical or mental impairment which has a substantial and long term adverse effect on his/her ability to carry out normal day to day activities Thompson and Thompson (2008) state that historically, people with disabilities were considered tragic, different or in some way devious. They were not allowed to work, mix with others or travel and many were placed in asylums. Ingstad and Reynolds, (1995) claims that, media representation of disability often relates to insanity and evil. This is evident in such things as super hero movies, where the bad character is often portrayed as physically deformed or mentally unstable. However, throughout history there have been people with impairments that in todays society would have been viewed as disabled, Franklin D Roosevelt, four times president of the United States, had polio. The poet Lord Byron (mad Lord Byron), who was born with talipes, known then as a club foot, and whose name today is still synonymous for someone dashing, Byronic. Admiral Nelson, known for his great naval victories against the Napoleonic French and particularly the battle of Trafalgar, he is not viewed as disabled although he was blind in one eye and only had one arm. In todays society he would have been seen as a disabled seaman. But when we look at these people we do not see their disabilities, we see heroes, great leaders and writers. Did society just look past their impairment and just see their achievements?. (Ingstad and Reynolds, 1995). According to Finkelstein (1980), people with disabilities have existed in comparatively large numbers throughout the world and in different societies for centuries. What is also evident is that the cultural understanding and responses to impairment and disability have varied and still do. There is a real cultural stigma towards people that have any sort of physical or mental difference to the norm. This can be traced back to ancient Greek and Roman times. Finkelstein (1980) goes on to say that, all though the degree of bias has varied from time to time, peoples perceptions of impairment and disability have remained much the same since the industrial revolution in the nineteenth century. The start of the industrial revolution introduced the concepts of urbanization and paid labour. This brought new problems for people who were unable to compete for work. After being scrutinised and labelled by doctors and other professionals, these people were put in to hospitals or asylums where they remained for very long periods and sometimes indefinitely. This kind of treatment carried on throughout most of the western world and all through the first half of the twentieth century. Drake (1999), states that the Eugenic legacy, which looked at the assumptions of human mental characteristics, was in some way influential in forming a different outlook on impairments. Drake continues, the Eugenic legacy came to a logical conclusion during the systematic murders in the Nazi death camps of thousands of disabled people considered undeserving of life, worthless and a burden on society. In the 17th century impairments or disabilities were seen as punishments from God, and explained by using religion, superstition, or myths and legend. Some of these beliefs remain to this day such as the belief that a disabled person must have been evil in a previous life and is now being punished. (Campbell and Oliver 1995) I remember in 2003 former England manager, Glenn Hoddle was sacked from his position for saying that disabled people are paying for sins they committed in a previous life. But in other religious cultures in societies, disability may be seen as being chosen by god. (Campbell and Oliver 1995) Cultural values and Society can be responsible for imposing disability on someone with impairments. This is mostly done unintentionally or by misinterpretation but it results in excluding people with some form of impairment from participating in society. Therefore it is understandable that disabled people will see themselves, as an oppressed group. To understand this, there has to be a definition between the person with the impairment and the social construction, called disability. (Oliver 1996) What this means is that todays society defines the impairment as it is seen, i.e. the lack of a limb or limbs, organism or motor functions of the body that are not working properly, and the disability as the restrictions and disadvantages that go with it. Oliver, states that, We see disability as the disadvantage or restriction of activity caused by a contemporary social organisation which takes little or no account of people who have physical impairments and thus excludes them. (Oliver 1996, p22) The common view today, according to Campbell and Oliver (1995) is that a persons impairment is the cause of their disability and that their disability is a medical problem that has to be overcome. This refers to the medical model approach which focuses on prevention and cure. In many countries this has caused a growth of prosperous and costly industries involved with disability comprising voluntary organisations, drug companies, private businesses, charities and government institutions. These will be staffed by an army of professionals including support workers, doctors, nurses, occupational therapists and social workers. This attitude can have a negative effect on the way society see people with impairments and will result in stigmatisation. In addition to this, if society sees the impairment as the problem, surely it is logical to see that these problems must be cured or fixed in order for them to fit in to normal society. The outcome is that, people with disabilities are labelled as disabled people this may look like a play on words but what this shows is that the disability is seen before the person. Society sees people with disabilities as, not normal, this implies abnormal, and further reinforce the stigmatisation and stereotyping of people with disabilities being seen as inadequate and dependant. Are some people with disabilities more vulnerable than others According to Hales (1996, p152) Prejudice is a negative attitude towards particular groups of people based on negative traits assumed to be uniformly displayed by members of that group Hales uses the example, that it is commonly assumed, that younger people with learning disabilities have no interest in forming long term relationships, an adult sex life or having children. Hales describes this as issue as being social attitude rather than the physical disabilities faced by the people themselves. It is difficult to say if some people with disabilities are more vulnerable to discrimination than others as there are so many factors to consider. Cost for example. Barnardos (2011) state that, the costs involved in bringing up a child with a disability is much greater than raising non disabled children. Barnardos also state that, it may not just be the higher cost of living, no qualifications and unemployment that are causing discrimination. But the fact that living in deprived communities where the understanding of disability is lower than the more affluent areas. One fifth of children with disabilities live in poverty stricken areas, resulting in social exclusion, discrimination and causing multiple oppressions. (Barnardos (2011). Marginalisation and exclusion refers to people with disabilities not being included in everyday life. This includes non equality in the work place. (Barns and Mercer 2003) state that, while some benefits such as disability living allowance (DLA), are in place to help people cope financially with social and work factors, it can also have an adverse effect by highlighting a dependency on benefits. This again can lead to stigmatisation and oppression. New labour recognised this problem and developed the welfare to work policy in 1997. The government documented that unemployment for people with disabilities was far higher than it was with non disabled people. A high percentage of people with learning disabilities live in poverty. 24 % of working age people with disabilities do not have formal qualifications. (HM Government 2011) The government recognises a link between unemployment and social exclusion. In 1989 the government set up the social exclusion unit (SEU) to improve the educational prospects for children with disabilities. Although this was a step in the right direction, it is worth noting that the minister for education at this time was David Blunkett, who is classed as a person with a disability. (Dan 2005) When people think of disability they think of the obvious such as wheelchair users. There are some things put in place for people with physical disabilities. Examples of these are wider doors, ramps, higher power points, lower light switches, audio and visual aids, lowering busses and disabled parking (Hales 1996). But in my opinion people with learning disabilities seem to be less understood. Therefore, I feel that, it can be argued that people with learning disabilities are more vulnerable to discrimination than other. Why do some people reject the disability label and some accept it? According to Barnes (1991), some people will accept the disability label, feeling that they are not able to cope in society and they are in a sort of limbo, waiting for a cure and the hope that one day they may get fixed. This may be because they have been conditioned by a non disabled society to accept their lot in life; they are broken and need a cure. Some disabled people will obviously want a cure and will actively help in working to find one, thus giving their life some meaning and a reason to belong. Some need to succeed in order to belong, some need to belong in order to succeed. (Hill Country Disabled Group) According to Clapton Fitzgerald (1997) this stems back to the medical model of disability that perceives impairment as something that has to be fixed, i.e. a person is disabled because of their individual impairment so consequently they will require medical interventions to give them the skills to adapt in our non disabled society.   There are disadvantages to being labelled as disabled. But there can also be advantages. In my experience, in having dyslexia, (which was discovered while I was at university), I am classed as a disabled student. I do not see myself as being disabled as there are no physical signs of dyslexia and it is something I have lived with all my life without knowing. Initially, I resented the disability label, but in accepting it, I received the help I need to complete my course. Some of my fellow students see such a label as stigmatising, and even though they have similar pattern of difficulties, they did not want to seek help for fear of being labelled. There are the people who see disability as a social problem put on them by a non disabled society that impairs physically disabled people. It is argued that no one has made a specific distinction between biological impairment and social disability. (Clapton Fitzgerald (1997) This is seen as the key to the British social model of disability and was originally devised by disabled rights activists in the 1970s. This move forward was developed by disabled people and their own experiences of living with impairment in Western society (UPIAS 1976) The social model has been widely acknowledged and developed by disability rights groups all over the world. It is now the foundation and the principle way of thinking in regard to policy-making for countries as diverse as Japan, South Africa and the USA. The social model of disability is not complicated; it just highlights the cultural, economic and environmental barriers experienced by people who are seen by others as impaired. According to Barnes (1991), these barriers can include: education problems, communication issues, problems within the working environments, insufficient disability benefits, social support services, inaccessible transport, housing and public buildings and the devaluing of people labelled disabled by negative imagery and representation in the media such as films, television and newspapers. From this viewpoint it is easy to see why some people will reject the label of being disabled and see their disability as a failure by society to accommodate their personal and combined needs within the confines of conventional society. (Barnes 1991) What can be done to effectively counter discrimination? Oliver (1990).explains that, peoples perceptions of disability and rehabilitation are changing. The 1960s saw the start of this change with politicians, policy makers and social workers realising that the world can no longer look at the disability issue as an individualistic medical problem, (Barnes and Mercer 2003). One of the reasons for this is that people with any form of impairment, be it cognitive or physical, are seen as abnormal and labelled as disabled. The fact is, that these people represent a growing segment of the global population and must be treated as equals. In brief, this means that the social model of disability is a tool to help us recognise the disablement caused by societys preconceptions of people with disabilities and help improve policy making. (Oliver 2004) Ten years ago, Glasby and Littlechild (2002), stated that, what is needed to effectively counter discrimination is to move away from government run professional services. They foresaw a need for greater investment in user led initiatives, especially regarding direct payments. This should give thousands of disabled people across the UK a better chance of achieving real independent living. Glasby and Littlechild go on to say that this could be achieved by setting up a new national body working directly with the National Centre for Independent Living (NCIL). Along with the distribution of direct payments, this new organisation could produce a standardized assessment for direct payments, reducing mistakes and making it easier for service users. Barns (2004) explained that, such an organization could also monitor local user groups that provide services for direct payment users. This would also give this new organisation the opportunity to benefit from a wealth of experience and expertise that has been developed by disabled people for over twenty years. (Barns 2004) The problem at this time was that, the government authorities were reluctant to implement direct payment policy for a number of reasons. Nowadays, direct payments are offered as a matter of course. During my third year placement in social services, It was actively encouraged to offer this service, in fact, I could not complete a unified assessment without doing so. We also recognise organisations such as the Rowan. This is a registered charity that provides direct Payment and Personal Budget support for service users. The Rowan has a vision of, A society that is fully inclusive in which the barriers, whether environmental, attitudinal or institutional, that prevent disabled people from having equality of opportunity have been removed. (The Rowan Organization 2012) As social workers we have the training to act in a non discriminatory way. We follow guidelines in our codes of practice such as, upholding public trust in social services and not unlawfully discriminating service users. Anti discriminatory practice is fundamental to the practice of good social work. It is important not to assume what difficulties people have with their disabilities. This in itself is a form of oppression, as only people with disabilities will know what its like to face disability discrimination. I feel that one of the most important roles as a social worker is advocacy. This will ensure that the voices of peoples with disabilities are heard. Legislation is main area that can help fight discrimination and oppression. The Equality Act 2010 enforces a duty on employers to make adaptations that will aid disabled people in the work place. This act also makes it illegal to treat people differently because of their disability. According to Barns (2003), the equality movement and looking into the problems of disablement has brought forward the concept of independent living. This concept was first used in the United Kingdom during the 1970s, after being adopted by disability activists in the USA. These activists called themselves the ILM or independent living movement. This movement was partly developed within campuses of American universities and partly from the on-going efforts of the disability activists who were attempting to influence, not only US disability legislation in the 1960s. But also, peoples discriminating perceptions of disabled people. Disability Wales ran a campaign from April 2010 to March 2011. This was called independent living now. This highlighted six main calls to action that disabled people had deemed essential in further development of Independent Living. These are: 1. Improved access to information, advice, independent advocacy and peer support services for all 2. Availability of accessible and supported housing to meet individual requirements 3. A comprehensive range of options and genuine choice and control in how personalized care and support is delivered 4. Improved access to Person Centered Technology (aids equipment) 5. A barrier free transport system, including all modes of transport 6. Enabling access, involvement and social, economic and cultural inclusion for all disabled people. This concept of independent living is a broad one and is usually associated with younger and middle aged people with physical and sensory conditions. But this concept does apply to everyone in the disabled population. This includes people with high support needs and people with cognitive conditions such as learning disabilities and mental illness (Barnes 2003). Because of this, independent living does have some criticisms. My own experience of working with a young man who had learning disabilities was not very successful. This person was granted independent living and was given his own flat. The problem was that all his friends did not have any kind of impairment. This was causing real problems as they were encouraging him to spend his disability allowance on alcohol and having parties at his flat. In turn this was causing problems with the neighbours because of the constant noise. This also resulted in him not having any money for food and being drunk most of the time. This was caus ing him to have health problems, which resulted in him being returned home to his parents. Conclusion In concluding this assignment, I have discussed why there is disability discrimination both from an historic and societal point of view and how people are disabled by these views. I have also discussed the different levels of vulnerability and who I feel are the most vulnerable in our society. In addition, I have covered why some people accept the disability label whilst others reject it, and what can be done in the hope of effectively countering disability discrimination. 3249 words Acts Disability Discrimination Act 1995. Equality Act 2010

Analytical Test Methods in Downstream Processing

Analytical Test Methods in Downstream Processing Andrea Waldvogel Validation of Analytical Test Methods in Downstream Processing Introduction Quality, safety and efficacy are the main principles of quality assurance of biopharmaceutical drug products. Quality must be designed into the product or process since it cannot be tested into it. Therefore, a quality system must comprise of validation, change control, training, quality control and vendor assurance amongst others.1-3 An effective validation does not only provide a high degree of confidence that the finished drug product consistently and reliably meets all quality requirements but also leads to economic benefits by reducing the cost associated with process monitoring, sampling and testing.4 Biopharmaceutical companies must perform facility, utility and equipment validation/qualification, process validation, computer and computer systems validation, cleaning validation and analytical method validation.5 This project report will focus on analytical method validation, also referred to as analytical procedure validation. Analytical methods are developed to measure characteristics such as molecular identity, purity, potency, and safety of raw materials, in-process samples and final drug products and to monitor the manufacturing process. The number of tests should be adequate to show manufacturing consistency and the impact of changes on the quality of the drug product. All methods must be demonstrated to be fit for their intended purpose before they are employed.5,6 Analytical method validation means establishing documented evidence that provides high degree of assurance that a specific method, and the ancillary instruments included in the method, will consistently yield results that accurately reflect the quality characteristics of the product tested.7 This report begins by providing an overview over some of the regulations and guidelines related to analytical method validation. The second section introduces the modern lifecycle approach to method validation and section three gives an insight into analytical method validation in biopharmaceutical downstream processing. The final section concludes the report with a summary of the main points discussed. There are many different regulations, guidelines and pharmacopeial monographs concerned with analytical method validation. As it would go beyond the scope of this document to write about all of them, the report focuses on some to give an overview. 1.1 Regulations Validation is based on, but not prescribed by regulatory requirement. It is best viewed as an essential and integral part of Good Manufacturing Practice (GMP) for the assurance of quality. Compliance with validation requirements is necessary for obtaining approval for clinical trials and to market new products.4 In the U.S. for example, 21 CFR Part 211.165(e) states8: The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with  § 211.194(a)(2). 21 CFR Part 211.194(a) (2)8: A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (à ¢Ã¢â€š ¬Ã‚ ¦). The suitability of all testing methods used shall be verified under actual conditions of use. The requirement of validation is also implied in 211.100(a)8: There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 1.2 Guidelines The first guidance documents on analytical method validation were published in the 1990s. In the course of time, a lot of revision activity has taken place allowing the incorporation of new approaches to science. The harmonised ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology guideline, issued in 2005, is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures and has tended to take on the role of a regulatory expectation. In the United States, it has been used as a guidance along with the related compendial documents USP Analytical Procedure Validation, Analytical Procedure Verification, and Analytical Procedure Transfer. However, those documents do not provide support for the users to accurately understand and control sources of variability.6,9 In 2013, a Stimuli to the Revision Process paper on Lifecycle Management of Analytical Procedures published by the USP Validation and Verification Expert Panel proposed a Quality by Design (QbD) approach to method development, validation, and performance verification of an analytical method via a lifecycle concept. They suggested that the traditional approaches outlined in the U.S. Pharmacopeial monographs , , and should be revised and assembled into a single new general information chapter Lifecycle Management of Analytical Procedures and a new general chapter specifying the basic requirements. This would, for the first time, formally link method development and method validation within pharmacopeia.6,10 In 2016, a general chapter prospectus on The Analytical Procedure Lifecycle was posted on the U.S. Pharmacopeial Notices and a draft of a new USP General Chapter Statistical Tools for Procedure Validation was published in the U.S. Pharmacopeial Forum (U.S. Pharmacopeial Convention).11,12 In August 2017, a new general USP Chapter Validation of Compendial Methods will become official. This is an effort to better align the validation concept with the revised FDA guidance for industry Analytical Procedures and Methods Validation for Drugs and Biologics issued in 2015. However, instead of including a section on Lifecycle Management of Analytical Procedures only a reference has been added. Depending on the development of the chapters and , USP may be revised again.13 Growing awareness that the implementation of an analytical method with adequate quality steps designed into the procedure during the development phase led to the development of a lifecycle approach for analytical procedure validation.10 2.1 Stages of the Modern Lifecycle Approach The modern lifecycle approach is based on the Quality by Design (QbD) approach outlined in ICH Q8(R2) guideline and defines activities and deliverables for every stage of method validation. The following diagram provides an overview. Figure 1: QbD Approach for Analytical Methods 2.1.1 Stage 1: Procedure Design, Development, and Understanding To be able to design quality into a method to ensure that the method is reliable and meets the analytical target profile (ATP) defined at the beginning of this stage, an understanding of how the procedure works is key. Risk assessment should be undertaken to identify variables that could have an influence on the method. The knowledge of variables and their impact is not only important for the development of a control strategy but also for the determination of a design space. The design space will reduce the amount of revalidation work considerably when the method is used operationally. Key elements of this stage are shown in Figure 1 no. 1-3.10 Proper method development including the evaluation of robustness is essential for an effective analytical procedure.10 Robustness is a measure of the methods capacity to remain unaffected by small variations in method parameters and provides an indication of its reliability during normal usage.9 At this stage, system suitability parameters are established which help to ensure that the analytical method remains valid whenever used.9 Without developing a robust method and an understanding of how a change of key parameters will impact its performance, the actual method validation step will be difficult.10 2.1.2 Stage 2: Procedure Performance Qualification The lifecycle approach uses the term procedure performance qualification instead of method validation. Procedure performance qualification is the verification of the performance of the analytical procedure (either a new one or a revised procedure) against the requirements of the ATP.10 If the procedure development has been done correctly, this step should simply be a confirmation that it is fit for the intended purpose. In cases where further controls need to be added to ensure reliable results the analytical control strategy, developed during stage 1, will need an update.10 Method validation work should be performed by a user laboratory under the same conditions as it will be used to comply with existing GMP regulations.10 2.1.3 Stage 3: Implementation and Continued Procedure Performance Verification This stage involves checking how the procedure works during operational use and that it remains in a state of control.10 For this purpose, inputs on reliability and performance of the method gathered from operators and customer complaints will be evaluated. Performance indicators such as system suitability, quality control samples and out-of-specification (OOS) results are tracked and trended.10 The method should be continually improved through corrective and preventive action to reduce the number of out-of-specification (OOS) results. Any change to improve the overall performance needs to be assessed using change control procedures. As shown in Figure 3, the nature of the change specifies what actions have to be taken.6,10,14 Figure 2: Change Types and appropriate Actions 2.2 Traditional (Current) Approach vs Lifecycle Approach In their Stimuli to Revision paper, the USP Expert Panel recommends the adoption of a lifecycle approach for the management of analytical procedures. In their conclusion, they outline the advantages of a lifecycle approach by comparing it to the traditional (current) approach to analytical procedure validation (Figure 1).6 Downstream processing in biopharmaceutical manufacturing involves many steps from recovery over purification to fill finish. Next to in-process monitoring of process parameters such as pH and temperature, analytical testing for the determination of quantity, identity, strength, potency, purity (product- and process related impurities), bioburden and endotoxin has to be performed on raw materials, intermediates, drug substances and finished drug products. Some of the analytical methods in downstream processing are HPLC, gel electrophoresis, PCR, ELISA, Bradford, hemagglutination (HA) and plaque assay. All critical steps in a process have to be validated and less critical steps have to be under control. The criticality of an analytical method is determined by risk assessment. There are various ways to perform method validation. The manufacturer is responsible for choosing the suitable validation procedure and justifying it.1,7,9 3.1 Types of Analytical Procedures The four most common types of analytical procedures are identification tests, qualitative and quantitative tests for impurities and assay. Assay involves the quantitative measurement of the major component(s) in the drug substance and drug product.9 3.2 Team Selection The validation project manager is responsible for the selection of a Cross-Functional-Team (CFT) from various related departments and functional areas. He or she is also in charge of assigning responsibilities and assuring that all personnel involved are trained properly.7 3.3 Analytical Method Validation Protocol The first step in method validation is the preparation of a protocol that defines the work to be done to demonstrate that the method is fit for its intended use.7,10 The analytical method validation protocol should contain the following sections: Purpose Short description of what is to be accomplished Scope of the project specifying the test methods and products Overview General description of the test method Summary of the characterisation studies Identification of method type and validation approach Test method applications and validation protocol Intended use of each test method application Analytical performance characteristics for each test method application Resources End user laboratory where the method validation is to be performed Equipment and materials to be used in the method validation Special instructions on handling, stability, and storage for each material Appendices References, signature, and a review worksheet for all personnel Specific tasks for all personnel and documentation of their training Listings of all equipment and software necessary to perform the method validation Document and materials worksheets used in method validation Test method procedures (SOPs) Before the method validation can begin the protocol must be agreed upon by the CFT and approved.7 3.4 Performance Characteristics Tests Performance characteristics and their acceptance criteria are defined during the characterisation studies at the development stage of the analytical method. Depending on the method and its intended use, some performance characteristics tests may be omitted, the number of replicates may be increased or reduced, or acceptance criteria may be adapted. All decisions have to be based on scientifically sound judgment. It is important that well characterised reference materials, with documented purity, are used for testing performance characteristics.7,9 The following table outlines the performance characteristics and their meaning, test procedures, how data should be reported and acceptance criteria according to ICH Q2(R1) and FDA Guidance for Industry on Analytical Procedures and Method Validation. Accuracy Closeness of test results to the true value For drug substances, accuracy measurements are obtained by comparing test results to the analysis of a standard reference material or to a second, well-characterized method. For drug products, accuracy is evaluated by analysing synthetic mixtures (containing all excipient materials in the correct proportions) spiked with known quantities of analyte. Guidelines recommend that data be collected from a minimum of nine determinations over at least three concentration levels covering the specified range. The data should be reported as the percent recovery of the known, added amount, or as the difference between the mean and true value with confidence intervals (such as  ±1 SD). Acceptability criteria are defined by end users but rarely fall outside 97-103% of the nominal value. Statistical analysis can be applied using a one sample t-test. Precision Degree of agreement among test results when the method is applied repeatedly to multiple samplings of a homogeneous sample Precision is commonly described in terms of repeatability, intermediate precision, and reproducibility: Repeatability is investigated by analysing a minimum of nine determinations using the same equipment and sample, covering the specified range of the procedure, or a minimum of six determinations at 100% of the test concentration and reported as percent relative standard deviation (RSD). Intermediate precision refers to the agreement among the results from a single laboratory, despite potential variations in sample preparation, analysts, or equipment. Reproducibility refers to the agreement among the results from different laboratories. Results are reported as % RSD, and the percent difference in the mean values between the analysts must be within specifications. Less than 2% RSD is often recommended, but less than 5% RSD can be acceptable for minor components. Specifity Ability to measure accurately and specifically the analyte of interest in the presence of other components In drug assays, specificity takes into account the degree of interference from other active ingredients, excipients, impurities, degradation products, or matrices. In chromatography, it ensures that a chromatographic peak corresponds to a single component. Specificity can be demonstrated by the resolution between peaks of interest. Limit of detection (LOD) Lowest concentration of an analyte in a sample that can be detected In a chromatography laboratory, the most common way to determine both the LOD and the LOQ is using signal-to-noise ratios (S/N), commonly 3:1 for LOD and 10:1 for LOQ. An appropriate number of samples must be analyzed to fully validate the method performance at the limit. Limit of quantitation (LOQ) Lowest concentration of an analyte in a sample that can be quantified with acceptable precision and accuracy under the stated operational conditions of the method Linearity Ability of a method to provide results that are directly proportional to analyte concentration within a given range Guidelines specify that a minimum of five concentration levels be used to determine the range and linearity, along with certain minimum specified ranges depending on the type of method. The range is normally expressed in the same units as the test results obtained by the method (for example, nanograms per millilitre). Data to be reported generally include the equation for the calibration curve line, the coefficient of determination (r 2), residuals, and the curve itself. Range Interval between the upper and lower concentrations of an analyte that have been demonstrated to be determined with acceptable precision, accuracy, and linearity using the method Robustness Measure of a methods capacity to obtain comparable and acceptable results when perturbed by small but deliberate variations in procedural parameters It provides an indication of the methods suitability and reliability during normal use. During a robustness study, method parameters (such as eluent composition, gradient, and detector settings) are intentionally varied to study the effects on analytical results. Common chromatography parameters used to measure and document robustness include critical peak pair resolution (R s), plate number (N) or peak width in gradient elution, retention time (t R), tailing factor (T F), peak area (and height) and concentration. Robustness studies are expected to be done during method development. Table 7 gives an overview of the performance characteristic tests that have to be performed on different types of analytical procedures.9 Figure 6: Performance Characteristic tests performed on different Types of Analytical Procedures The performance characteristics are evaluated by comparing the results to the specifications defined at the development stage. An analytical method is considered to be validated when it meets the specifications defined at the development stage. Once an analytical method has been made a formal part of the manufacturing process, it is extremely difficult to remove it. In the event of changes in the drug substance, the composition of the finished product and in the analytical procedure, revalidation may be necessary.5,7,9 3.5 Validation Documentation Every validation step needs to be documented to be able to provide written evidence to the regulatory authorities that a specific method is fit for its purpose. Documentation associated with method validation are validation protocols, standard operating procedures (SOPs), specifications and validation reports. Downstream processing in biopharmaceutical manufacturing involves many analytical methods which help to ensure quality, safety and efficacy of the final drug product. Development, validation and control of a robust analytical method is a lengthy and difficult task. However, without written evidence that an analytical method is fit for its intended use the company will not obtain a marketing authorisation. Over time, many guidelines and pharmacopeial monographs have been issued and a lot of revision activity has happened especially following the Stimuli to Revision paper published in 2013. Even though, no comprehensive guideline or monograph incorporating the modern lifecycle approach has been issued yet. Although proper development of robust and effective analytical methods is more time-consuming and expensive, it has many advantages. It leads to more efficient validation, variability is reduced and controlled and analytical method-related out-of-specification results and failure investigation are minimised. Additionally, changing method parameters within the design space facilitates continual improvement as it does not require regulatory re-approval. Validation is a team effort. Members of the CFT need to be properly trained. Their first and most demanding task is the preparation of a protocol which defines the scope of the validation project and provides all details necessary for a successful validation. It also defines, depending on the type of the analytical procedure, which performance characteristics need to be tested. The use of well characterised reference materials with known purity is important. Analytical method validation is considered to be complete when all acceptance criteria are met and a validation report has been written.       Bibliography References 1 Choudhary, A. (2009). Validation in Pharmaceutical Manufacturing. Pharmaceutical Guideline. [Accessed on 1 March 2017]. Available on Internet: http://www.pharmaguideline.com/2010/12/validation.html 2 International Conference on Harmonization (2009). Harmonised Tripartite Guideline: ICH Q8(R2) Pharmaceutical Development. [Accessed on 1 March 2017]. Available on Internet: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf 3 Stockbridge, P. (2008). Biopharmaceutical Fill and Finish: Technical and Operating Challenges for the Latest Formulations and Devices. BioProcess International. [Accessed on 7 March 2017]. Available on Internet: http://www.bioprocessintl.com/2008/biopharmaceutical-quality-assurance-184041/ 4 Nandhakumar, L.; Dharmamoorthy, G.; Rameshkumar, S.; Chandrasekaran, S. (2011). An Overview of Pharmaceutical Validation: Quality Assurance View Point. IJRPC, 1(4). [Accessed on 1 March 2017]. Available on Internet: http://www.caidat.org/m4atomp3/2561456335400862.pdf 5 Lutz, H. (2005). Introduction to Validation of Biopharmaceuticals. BioPharm International. [Accessed on 1 March 2017]. Available on Internet: http://www.biopharminternational.com/introduction-validation-biopharmaceuticals 6 USP Validation and Verification Expert Panel (2013). Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. Stimuli to the Revision Process Article. [Accessed on 1 March 2017]. Available on Internet: https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/lifecycle_pdf.pdf 7 Shabir, G. A. (2004). Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry. IVT Network: Analytical Method Validation, pp. 4-14. [Accessed on 2 March 2017]. Available on Internet: http://www.ivtnetwork.com/sites/default/files/Analytical%20Method%20Validation.pdf 8 U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Parts 211.165(e), 211.194(a) and 211.100(a). [Accessed on 2 March 2017]. Available on Internet: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=211 9 International Conference on Harmonization (2005). Harmonised Tripartite Guideline: ICH Q2(R1) Validation of Analytical Procedures, Text and Methodology. [Accessed on 1 March 2017]. Available on Internet: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html 10 McDowall, R. D. (2014). GLP and GMP Approaches to Method Validation Going the same Way?. Spectroscopy, 29(4). [Accessed on 1 March 2017]. Available on Internet: http://www.spectroscopyonline.com/glp-and-gmp-approaches-method-validation-going-same-way 11 U.S. Pharmacopeial Convention (2016). General Chapter Prospectus: The Analytical Procedure Lifecycle. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/notices/1220-analytical-procedure-lifecycle 12 U.S. Pharmacopeial Convention (2014). New USP requirements for Analytical Method Validation. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/pharmacopeial-forum 13 ECA Academy (2017). Revised USP Chapter Validation of Compendial Methods approved. [Accessed on 2 March 2017]. Available on Internet: http://www.gmp-compliance.org/gmp-news/revised-usp-chapter-1225-validation-of-compendial-methods-approved 14 Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/flyers/Public/Recent_regulatory_updates_and_trends_in_analytical_method_validation.pdf Illustrations Figure 1: Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/fl

Hamlets Insanity :: essays research papers

The question of Hamlet’s insanity is a question raised by many people, is Hamlet a great actor, or has he lost complete sense of what’s real? There is no right answer, there is no wrong answer, many readers have different perceptions on what really was going through Hamlet’s head. My perception is that hamlet comes full circle with his insanity, and at points lets it get the best of him, and brings him down to a extremely low point.   Ã‚  Ã‚  Ã‚  Ã‚  In the beginning of the novel that Hamlet’s spirits aren’t all there, and his soul is disturbed, by the death of his father. He seems to be looking for answers and meaning to explain the unexplainable death of his father and his mother’s abrupt marriage to his uncle, this is where I believe his insanity started. Given that this happened to anyone normal person, they’re mind would be a mess and bitterness and anger would play a huge part in their thoughts. So, yes in a way, I do believe that Hamlet was diseased with temporary insanity.   Ã‚  Ã‚  Ã‚  Ã‚  The Ghost of Hamlet’s father, was in way another brick of burden for Hamlet to carry, and did nothing but add confusion and anger to his already disturbed mind. After this I believe hamlets madness to grow, he his blinded by bitterness and anger towards his uncle so much that he loses sight compassion for life and love.   Ã‚  Ã‚  Ã‚  Ã‚  Hamlet truly loved Ophelia, In my eyes, and I do believe that if his mind was not clouded with anger, he would’ve done nothing to ever harm her. Hamlet without even realizing, because of his insanity used Ophelia as a release for his anger, and eventually drove her mad. He basically tortured Ophelia without even knowing, not only by the progression of anger and rejection towards her, but also by killing her own father.   Ã‚  Ã‚  Ã‚  Ã‚  The killing of Polonius, I believe to be Hamlet’s peak of insanity, the fact that he killed a man without even knowing who it was nor caring, I have to say is insanity at its best. Hamlet seems to have no perception of reality nor compassion at this point, his anger towards his uncle has completely blinded him and messed him up beyond belief. Another sign of Hamlet’s insanity is that he completely rips into his mother. There are very few people in this novel, I believe Hamlet to truly care about, but one person is definitely his own mother.

What drove Eliza to change? What does it mean to be high class? Essay

In George Bernard Shaw’s didactic, Victorian play Pygmalion, Linguistics Professor Henry Higgins’s perceptive ears are offended by the sound of Eliza’s lowly, Cockney accent, so he wishes to change it into a flawless, pleasant voice that would blend in among high society. Higgins is a sarcastic and rude character who treats Eliza badly throughout most of the play, sometimes not even acknowledging her presence. This brings up the question of why she tolerates his rudeness. What drove Eliza to change? Change is desired when we face conflicts that must be resolved. Another question this play presents is: What does it mean to be high class? Is it as Henry Higgins says it is, that it is just the proper way of speaking? Can the â€Å"right† sociolinguistics or money or heritage give someone high status? We can wish to change when wanting to improve ourselves, to satisfy others who we hold in esteem, to meet demands placed upon us, but most importantly, a successful change must come from self-motivated reasons. A change forced upon a person is like no change at all. After the pressure, the expectations, the possible threat of that comes with authority, have all been removed, a change can only last if the subject being changed had wanted to be changed in the first place. Initially, she wanted to improve her speaking voice so that she could find a better job, and with a better job, better prospects in every part of her life. She realizes that she can do this with Higgins’s help—she recognizes his expertise in this subject, but he is unwilling to help her until she pays him a high sum that she cannot afford. Higgins’s peer Colonel Pickering’s attention is brought to Eliza’s plight and he feels for her, so he strikes up a wager with Higgins and ... ...see any kind of challenge in Freddy, so he was not of so much interest to her. George Bernard Shaw’s message, though, is that affection for another person should not be disguised as distaste, for eventually, the person we love will move on to somebody else who treats him or her as he or she deserves to be treated. In a way, Eliza’s plan to marry Freddy is a type of poetic justice against Higgins, who, even though exhibits the proper grammar and speech of gentility, is not truly a gentleman. His behavior and attitude are just inexcusable for a heroine like Eliza. From this irony and dark humor in Pygmalion, we learn that we should be genuine and reveal our true feelings for a love interest eventually, even if it is slowly to keep ourselves from being hurt—we do not want to meet Higgins’s lonely fate. He could have had Eliza, but his caustic behavior kept them apart.

Structural Engineering Mishaps and Disasters :: essays research papers

Structural Engineering Mishaps and Disasters Hindenburg: An Unnecessary Disaster   Ã‚  Ã‚  Ã‚  Ã‚  In the 1930s airships, better known today as â€Å"blimps†, were the main source of air travel. During this time, the airships were used for various different reasons such as: bombing enemy targets, patrolling coastal areas, escorting naval ships during the night or through unsafe bodies of water, or used to make luxury flights across the Atlantic. The Hindenburg was believed to be the biggest and most sophisticated aircraft ever built.   Ã‚  Ã‚  Ã‚  Ã‚  The Hindenburg was built with metal framework and balloon like covering. It was as long as three football fields and weighed more than 240 tons. This airship looked ravishing, however, it possessed a significant flaw that eventually caused it to ruin. The outer skin of the Hindenburg was filled with hydrogen, which is extremely flammable. Passengers preparing to board the aircraft had to remove all lighters, matches, and/or any other objects that would cause it to catch fire.   Ã‚  Ã‚  Ã‚  Ã‚  Traveling all the way from Europe, the Hindenburg was expected to arrive in the United States and land in New Jersey on May 6, 1937. Max Pruss was commander, there were thirteen passengers, and twenty-two crew members on board . Hundreds of people waited for the Hindenburg, including: relatives of the passengers, news reporters, photographers, New Jersey citizens, and ninety-two ground crew members.   Ã‚  Ã‚  Ã‚  Ã‚  The flight’s landing was slightly delayed due to thunderstorms and aggressive winds. Finally, the weather calmed and the Hindenburg airship began to land in Jersey. One of the spectators noticed a pale pink glow in the lower center of the ship. Everyone began to become intense because they had a feeling that the glow was not suppose to be there. A few seconds later that section of the airship exploded! All the onlookers, of course, backed away rapidly, but were still close as the entire Hindenburg airship, and mostly all of its passengers caught fire.   Ã‚  Ã‚  Ã‚  Ã‚  Some parts of the Hindenburg did, in fact, remain together, but they are only preserved today for research. One of the passengers aboard the flight, a fourteen year old, climbed through a window trying to escape the fires of the airship. To his advance, one of the water tanks burst and the flames on his clothes and his body were extinguished.   Ã‚  Ã‚  Ã‚  Ã‚  The U.S Bureau of Air Commerce gave the following statement as an explanation of the explosion. â€Å"A small amount of explosive mixture (hydrogen) in the upper part of the ship could have been ignited by†¦{an} electric phenomenon like a ball of lightning.

Brain death determination

Brain Death Determination When the brain has a lack of oxygen, even for a few minutes, it could lead to loss of brain functions such as a gradual loss level of consciousness or a complete loss of consciousness causing the person to slip into a coma. In the most profound cases, irreversible brain damage and death occurs. Oxygen deficiency can by caused by many things, such as; a brain injury, fall from height, traffic accidents, heart failure, stroke or some neurological disease. That may cause irreversible loss of the brain cells performance.The medical term for insufficient oxygenation to the brain is referral Anglia. Historically, before recent technology the scientists defined death only when the heartbeat and breathing stopped. Afterward, the idea of brain death was announced in 1959 by French neurologists' Moldable and Gluon. They determined this state as â€Å"beyond coma† (D*mice et al. , 2004). Then after around ten years, within the medical community the development o f many types of equipment became available which aided in increasing the longevity of individuals with serious injuries to the brain.Some examples of these devices are ventilators to maintain respiration and heart monitors. These innovations in medicine made the concept of brain death clearer by closely showing the relationship between the respirations or heartbeat and brain. These innovations in the medical field guided the Harvard Medical School Committee to clarify that idea in 1968 (Sass, 2014). After that, it was medically defined as permanent loss of all brain functions, including cerebrum and brain stem due to total death of brain neurons that is caused by decrease of blood flow and oxygenation into the brain (ibid).This essay will discuss the main brain regions that have immediate cause of brain death and their functions, including the required tests of these regions, both clinical and confirmatory, for instance, the Electroencephalogram. The brain carries two major parts, c erebrum and brain stem. When they have any cause of damaged that might be a final result in brain death. Each one has primary roles in a person's life, because they are responsible for the main operations in human survival, especially the regulation of cardiac and respiratory functions.The cerebrum is the largest part of the brain and divided into two hemispheres (Fall & Bergman, 1998). There are main functions for he brain cerebrum without them no human can live. It is important to be concerned with functional specialization of different regions of the cerebrum to guide the treatment of the physician and assists them in making the right diagnosis. The cerebrum has a large primary sensory area, which is responsible for general sensation, for example, smell, vision, and hearing.The motor area is responsible for controlling the skeletal muscles, and the association area of the cortex has operations similar to the sensory areas but more complicated such as behavior, communication and i ntellect (ibid). Secondly, the brain stem is located in the posterior division of the brain and connected to the spinal cord. Beside that it includes three significant parts; medulla obbligato, pens and mandarin. Each one controls principal performance and it is the pathway of sending and receiving sensory information signals from the body to the brain.It has other important functions that have a major affect on a person such as regulation of the respiratory system, consciousness, alertness and awareness (Kiering & Barr, 2009). In general, both cerebrum and brain stem damage may end a arson's life because they contain all the regulation centers for all of the most critical functions that are needed to sustain life. There are many criteria to diagnose brain death. Each country has their organization, but there are general rules and guidelines in determining brain death for patients worldwide.There are important tools to consider when deciding whether the patient is dead or not, befor e the process of diagnosis of death by the criteria. The first tool is a person who is approaching the protocol of brain death qualified? For example, an ICC physician, an anesthesiologist, an internist, a neurosurgeon or a neuron physician are allowed and qualified to perform the tests because they have studied and trained to diagnose brain death, but a dermatologist or an ophthalmologist they have not done training on that.Although, they need to know the state of the patient and must be in a coma with ventilator support and the cause of their comatose condition must be rolled out, for instance, Head trauma, Cardiovascular hemorrhage, cerebral Anglia or primary brain tumor. Next, the cause of brain damage must be clarified six hours before tarring brain functions evaluation. Finally, the patient should not be hypothermia and body temperature has to be above 34 C or 32 C in some countries protocol and the person should not be under sedatives, muscle relaxant, anticonvulsant†¦ E tc Drugs for at least the previous five days. When these tools completed correctly the physician can start the diagnosis in following exam steps. The first clinical examination is to confirm that the patient is in a coma and to make sure a patient is not having any seizure activity in the brain. Furthermore, the physician needs to test he absence of motor response by painful stimulation for both hands and feet. It is required to do these evaluation exams on the standard method before starting the brain stem reflexes test because each exam depends on the previous one to give correct final result.Once the physician has done from the previous evaluation he will start the brain stem reflexes tests, which called the first clinical examination. These are five different exams and begin with papillary response. The light stimulation to test the pupil response by bright beam of light on both eyes, for example, a pen alights. Also, corneal reflex is involuntary blinking and has to be tested v ia a wisp of cotton wool to touch the cornea. Thirdly, cool-cephalic reflex it does perform by moving the head to a different direction and monitor the retina changes during the head movements.Fourthly, vestibule-ocular reflex this another test to activated eye movements by injecting both ears about 50 ml of ice-cold water or saline for adult, but children, less than 20 ml may be used. After all, upper and lower airways stimulation is produce either gagging or coughing. Furthermore, this exam's purpose or provoke the pharynx and trachea. For instance, using catheter leads down to reach into the pharynx and the trachea (Saudi center of organ transplantation, 2009). Accordingly, all those brain stem tests should result an absent responses to declare brain stem death.After finalization of the first examination, it's recommended to not start the second clinical test before 6 hours from the time of first exam end for an adult and after 12 hours for children (above 1 year),24 hours for in fants (above 60 days-I year) and 48 hours for neonate (7 days-60 days). Therefore to have enough mime to perform the confirmatory tests, such as Electroencephalogram (EGG) which is a machine that has 21 electrodes connected to the skull to cover all the brain regions and measures the electrical activity of the brain (ibid).In fact, the EGG and other confirmatory tests are optional in some countries but it is often helpful for the physician to prove that the brain is permanently damaged by having more than one test that confirms his diagnosis and prognosis. The next clinical exam is apneas; it is done to indicate the failure of involuntary respiration. This exam has a specific rotator to perform it, such as an increase the inspired fraction of oxygen without changing the ventilation rate, disconnect the patient from the ventilator for 10 minutes and supply a continuous flow of humidified air.These procedures are done to detect if there is any attempt for the patient to breathe (ibid) . Another test that is sensitive in analyzing the circulation in the brain is transitional Doppler (ETC) this examination detects the velocity of the blood that's circulating in the blood vessels supplying oxygen-rich blood to the brain. It uses ultrasonic waves that are focused onto a beam that is directed at different depths and angles by an experienced operator. The technologist uses sites on the skull where the bone is relatively thin and relatively close to the major vessels whose blood flow velocities are critical.One major vessel that supplies the brain is the Middle Cerebral Artery (MAC). When the blood flow circulation is compromised to the extent that survivability is not possible the ETC shows reverberating waveforms as the blood ceases to flow in it's normal direction and instead is ineffectually regurgitating back and forth without flow in espouse to the heart contraction. Later there are systolic spikes that indicate some increased pressure in the vessel with heart con traction but without effective flowing of blood through the vessel.The last signal that is compatible with brain death is a loss of signal entirely indicating no activity in the vessel and no recordable blood flow in the critical vessels of the brain. In conclusion, the concept of brain death has developed with period of the medical field improvements. The absence of a rich uninterrupted supply of oxygen is imperative to supply the brain and maintain unconsciousness and provide for the populations of neurons to continue to function properly.Trauma, disorders and diseases which impair circulation in the cerebral cortex and brain stem bring about a cascading assortment of symptoms that if not reversed results in death. The protocols and guidelines for brain death determination have been established for the safety of the patient to distinguish between patients who have suffered a life-threatening insult, but who may recover and those unfortunate individuals in whom there is no hope for recovery.