Monday, September 30, 2019

River Valley Civilizations

Approximately 5000 years ago the first complex, politically centralized civilizations began to form independently along numerous river valleys throughout parts of Asia and Africa. These civilizations were the building blocks for organization of human economic, political, religious, and social practices. Although the cultures of both Ancient Egypt and Shang China River Valley Civilizations share geographic, religious, and political similarities, the cultures are vastly different when social characteristics and economic trade are taken into consideration. Both Ancient Egypt and Shang China both developed closely to major rivers. The Ancient Egyptian River Valley Civilization was located along the Nile River which helped to provide a reliable source of water for farming. The Nile River current runs north-allowing movement along the river, and the winds blow from the north allowing sailing vessels to travel against the current. It was easy to travel and interact along the Nile. When the Nile would flood, it would naturally fertilize the surround soil with nutrient deposits that gathered within the river. The same thing would occur with the Yellow and Yangzi Rivers, which were located near the Shang China civilization. This is why both civilizations flourished when it came to crop production. Near the Yangzi River, however, people had to work harder at flood control and irrigation. It is said that perhaps this stimulated a greater effort at organization. Both Ancient Egypt and Shang China were both ruled by kings, too. In Ancient Egypt, they believed that the pharaoh had all the power and influence over his people. He was considered to be divine, stood above the priests, and was the only individual who had direct contact with the gods. This is similar to how the emperor was looked at in Shang China, where he was seen as a chief priest, and he had an administrative bureaucracy, with councilors, lesser priests and diviners. Emperors and aristocrats had splendid homes with walls of pounded earth or earthen bricks while common people continued to live in their pit homes of earlier times much like how the Ancient Egyptian pharaohs were built high class pyramid tombs after they became diseased. In both civilizations, the king figure was highly important and very much valued. They were often showered with gifts. However, unlike Ancient Egypt, women had no rights in Shang China. Women held many of the same rights as the men in Egypt. Women were allowed to own their own land and to share equal property with their husband once they married. On the other hand, in Shang China, the oldest member of the family controlled the family’s property and made the important decisions. Women were inferior expected to obey fathers, husbands and then later their sons. Each women may have had between 13 and 16 marriages arranged marriages without any ability to protest it, and only by bearing sons could she improve her status. Shang China used items such as wheat, mullet, and silk, for trade, where metals were more common for trade in Ancient Egypt. The Silk Road was used to open trade between Ancient China and Rome. People in China were the first to master the development of silk and they did so by raising silk worms and then collecting the silky web that they formed. They then weaved the web together to form a more substantial material. Wheat and mullet were also common edible items used for trade in Shang China because they had suitable temperate weather along with forested land. Using metals in trade was important for Ancient Egyptians because it was plentiful and could be made into an assortment of items from weapons to tools. Egyptians did not harvest the same type of grains as those in Shang China because they had too much of a dry climate that did not allow crops such as those to thrive.

Sunday, September 29, 2019

Pondy’s view in the “process of conflict” Essay

Pondy views conflict as a process consists of 5 stages – latent conflict, perceived conflict, felt conflict, manifest conflict and conflict aftermath. Managers can use Pondy’s model to interpret and analyze a conflict situation and take action to resolve it. In latent conflict, there’s no outright conflict but there’s a potential for several sources of conflict, such as interdependence, differences in goals and priorities, bureaucratic factors, incompatible performance criteria and competition for resources. As organization differentiate, activities of different subunits are interdependent. Each subunit develops a desire for autonomy and begins to pursue goals and interests that it values over the goals of other subunits. Since the activities of the subunits are interdepedent, subunits’ desire for autonomy leads to conflict between groups. Differences in subunit orientation affect the way each division views the world and cause each subunit to pursue different goals that are often inconsistent or incompatible. The potential for conflict arises once their goals become incompatible. This is because the goals of one subunit may affect the ability of anothe to achieve its goals. Latent conflict may also arise by the way which task relationships develop in organizations. Conflict can occur because of status inconsistencies between different groups in the organization’s bureaucracy. One of the bureaucratic conflict occurs between staff and line functions. A line function is directly involved in the production of the organizaion’s outputs while staff functions advise and support the line function such as personnel and accounting. In most organizations, people in line functions view themselves as the critical organizational resource and people in staff functions as secondary players. Thus, they always uses its status a the producer of goods and services to justiry putting its interests ahead of the other function’s interests. This results in conflict. Sometimes goals incapability are not the souce of conflict. However, it is because of the way organization monitor, evaluate and rewards different subunits. The way an organization designs its structure to coordinate subunits can affect the potential for conflict as well. Other than thses, conflict may arise because of the limited resouces as well. When resources are limited, choices aobut the allocation of them have to be made and the subunits will have to compete for their share. Divisions will have to fight to increase their share of funding because the more funds they can obtain, the faster they can grow. Perceived conflict is the second stage of Pondy’s model. Perceived conflict begins when subunits perceives that its goals are being thwarted by the actions of another group. Each group searches for the origin of the conflict and constructs a scenario that accounts for the problems that it’s experiencing with other subunits. For example, the manufacturing function suddenly realize that the cause of many of its production problems is defective inputs. After some investigation, they found that the materials management always buys inputs from the lowest-cost sources of supply and makes no attempt to develop the kind of long-term relationships with suppliers that can raise the quality and reliability of inputs. So, the manufacturing will perceive the materials management as thwarting its goal and interests. In felt conflict stage, subunits in conflict quickly develop an emotional response toward each other. Cooperation between subunits and organizational effectiveness will fall if conflict arises. The conflict arises as the different subunits in conflict battle and argue their points of views. The real problem may be relatively minor, but it will turn into a big conflict which become more and more difficult to manage if we didn’t resolve it. It will quickly reach the fourth stage, which is the manifes conflict if the conflict is not resolved. In the manifest conflict stage, one subunits gets back at another subunits by  attempting to thwart its goals. Open aggression between people and groups is common. There are many stories and myths in organizations about board-room fights in which managers come to blows as they seek to promote their interests. Infighthing in the top-management team is very common as managers seek to promote their own careers at the expense of others. Once manifest conflict occur, organizaional effectiveness will suffer because the intefration and coordination between managers and subunits will break down. Managers have to avoid conflict from reaching this stage. If the sources of the conflict was not resoved, it will cause conflict to occur again, but may be in another context. Every stage of conflict leaves a conflict aftermath which affects they way the parties percieve conflict and react to future conflict stages. The aftermath will promote good future working relationships if a conflict is resolved before it gets to the manifest-conflict stage. However, if the conflict wasn’t resolved, the aftermath will be worse future working relationships.

Saturday, September 28, 2019

The Times & Music of Johann Adolf Hasse Essay Example | Topics and Well Written Essays - 1750 words

The Times & Music of Johann Adolf Hasse - Essay Example Hasse was fortunate to have achieved considerable fame in his own lifetime- a fate reserved for very few composers in classical music (Millner, 1974 & 1979). Johann Adolf Hasse (1699-1783) was born in Bergdorf, one of the largest boroughs in Germany. He came from a family of church singers, organists and musicians. It was natural that he was to follow in their footsteps. Hasse’s father belonged to a musical family, and his great-grandfather Peter Hasse had been employed as an organist in Lubeck where had gained some fame as a composer in his heyday (Degrada, 1975). Hasse’s father and brothers subsequently were given the position of organists at the local church. His father was the head of a local charity organization which facilitated Hasse study in Hamburg. Hasse began displaying great musical talent at the age of fifteen. In fact during the very next year, in 1721 Hasse was hired by the Hamburg Opera Company as a tenor on the recommendation of Johann Ulrich Konig, who was the private secretary and poet to the Saxon Court at Dresden. Konig subsequently recommended Hasse for a position in the opera of the Duke of Brunswick. Hasse sang the operas of Caldara, Conti and Schumann. In 1721 Hasse’s creative talents came to the fore when he composed and sang his very own first opera role, Antioco. In fact, it was Hasse who gave life to the title role while Schumann sang the part of Seleuco. At the time, Italy was a burgeoning point for singing and operatic talent. After travelling through Venice, Bologna, Florence and Rome, Hasse eventually decided to settle down in Naples for some time (Grove, 1992). While in Naples, he met both Nicolo Pompora and Alessandro Scarlatti and he studied under both of them by 1725.

Friday, September 27, 2019

Research dissertation proposal Essay Example | Topics and Well Written Essays - 250 words

Research dissertation proposal - Essay Example The modern day society in multi-racial countries is of people from different backgrounds. Some races are considered inferior in some countries. This notion extends into the workplace whereby managers are prone to make impaired judgments on their employees based on their race. Some countries in the world consider members of the female gender inferior and incapable of serving some functions. On accessions, women in these countries are discriminated from performing some duties strictly set apart for men. The primary aim of the research entails shedding light on cases of workplace discrimination and helps create information that will improve how employment law prevents the effects of job discrimination (Hagelskamp, and Hughes, 2014). This dissertation will be based on information derived from a literature review. Information compilation will be through examination of selected literature material. A consideration of the previous literature from human resource departments across the public and private sector will be carried out. Trade union reports will be examined for the public sector. Human resource department reports from selected organizations will be considered for the private sector. Hagelskamp, C., and Hughes, D. L. (2014). Workplace discrimination predicting racial/ethnic socialization across African American, Latino, and Chinese families.  Cultural Diversity and Ethnic Minority Psychology,  20(4),

Thursday, September 26, 2019

Technologicial Entrepreneurship & Innovation Essay

Technologicial Entrepreneurship & Innovation - Essay Example Lack of communication and coordination, thus becomes an impediment on the invention. Individuals working alone do not have to manage teams and thus can fully concentrate on the work at hand. Jewkes also points out that research organizations hire people who may not be totally research driven. The passion to achieve something new is absent from many people working within an organization. For the individual worker, the passion is there since he utilizes his own resources and his efforts largely go unpaid. Despite this, the individual worker pursues his aim since he is driven by the passion of invention. However, research organizations set the pace for the invention which would otherwise be dependent on the inventor’s spark of genius which could take any length of time if the inventor is left to his own devices. While Jewkes fights against the concept of individuals working in teams, he also provides certain pros of the position. He believes that teams should be encouraged so as to provide support to the individual worker. According to Jewkes, the purpose of teams should be to help the actual inventor to gain support from the men who are under his command. Also Jewkes believes that teamwork has become imperative in this era of specialization. This is because as science and technology have advanced to new levels, it is difficult for the individual to know everything. This then demands the need for team work where members fill in the information required to work on complex tasks. b. Innovation arising among individuals or small enterprises vs. large, highly structured enterprises (about 500 words) Innovation arising among individuals is the preferred form of innovation in the opinion of Jewkes. To support this claim, Jewkes offers various examples as well as...Apple iPod was introduced in 2000 as a reaction to music players that were already in the market but none was as sleek as the Apple iPod. The ten stereotypes developed by Scott Burken do not absolutely hold true for this innovation. As times, the iPod defies the stereotypes and takes in own path. One stereotypes that iPod defies from the ten stereotypes is the reaction of the public towards the product. Previously consumers were using large music players that were bulky and not as convenient as the iPod, thus when presented with the iPod; they fell in love with it. Apple Inc. already had a reputation of delivery top quality innovative products and this reputation went along with iPod. Thus iPod was an instant success among the public since they were given a more beautiful and bigger machines for playing music than they previously had. Burken, on the other hand, asserts that innovations when introduced in the market do not receive the reaction that they do after some time. They fail to generate interest among the customers; however, this was not the case with Apple’s iPod. Another stereotype that Apple iPod defies is that it was developed under the guidance of Steve Jobs. Steve Jobs, before being an innovator, is a manager.

Wednesday, September 25, 2019

Summarization for 7 chapter of the weather makers Essay

Summarization for 7 chapter of the weather makers - Essay Example By going on to detail the level of environmental destruction, the footprint of human development, and the means whereby otherwise pristine regions have been reduced to little more than a wasteland, the author fully grips the reader’s imagination and attention with regards to the poignancy of the issues at hand. Likewise, Chapter 10, entitled â€Å"Peril at the Poles† focuses upon the key importance that the earth’s polar climates have with relation to nearly every other known and observable weather pattern that climatologists track. Moreover, rather than merely relating the direct effect that a warming arctic region portends for other world weather patterns and the overall sea rise that such temperature increase necessitates, the author spends a great deal of time discussing how the delicate balance of life within the ecosystems are being intimately affected by the temperature changes. Examples of the close interconnected nature of krill, seal, polar bear, pengui ns, and caribou are all discussed as the author lays out the case for how temperature change bears the threat of acting as a veritable wrecking beam for an otherwise complex and interdependent ecosystem. Chapter 11, entitled â€Å"The Great Stumpy Reef?†, details the means by which human action has and continues to have a profound effect on the development, loss, and evolution of the coral reefs that dot the globe. As the author points out, the destruction of the coral reefs cannot be understood within the same context as the destruction of the ice shelves that have been discussed earlier; rather, human activity, pollutants, and other factors mean that the nature and extant species represented within the coral reef are necessarily changed. In this way, human actions and pollutants can encourage one species to shift the balance and develop a primacy for food and resources that necessarily puts another species at the brink of destruction within the region or worse yet, extincti on. Chapter 12, entitled, â€Å"A Warning from the Golden Toad† takes the level of analysis down even further into the realm of the individual species that is affected by the changing nature of the planet’s weather conditions. Such is very much the case of the Golden Toad which became extinct due to the fact that its eggs were no longer suitable for survival within the changing climate. This is a powerful example as extinction due to climate change is a topic that had not been of particular notice within the field of science or evolutionarily biology before this occurrence. However, due to the existence and subsequent disappearance of the Golden Toad, meteorologists and biologists alike have reason to be alarmed. If definitive proof therefore exists that as a direct result of climate change it can be determined that a species has now left earth’s ecosystem, it is likely that such is an example of merely the tip of the iceberg. Due to the rapidly decreasing numbe r of species left on earth, this issue is cause for alarm. Chapter 13, entitled â€Å"Liquid Gold: Changes in Rainfall†, discusses the fact that there is a direct relationship to the increase in global temperature and the overall increase in rainfall. Although it may seem that rainfall increase is a good thing in a planet that more and more frequently suffers from desertification, the fact of the matter that the author seeks to acquaint the reader with is that this

Tuesday, September 24, 2019

Movement and Positioning in Stroke Patients Essay

Movement and Positioning in Stroke Patients - Essay Example The effects of stroke can be divided into two categories: impairments and disabilities. Impairments are changes in the body structure and function. Disabilities, on the other hand, are limitations in the performance of the activities of daily living. These can be affected not just by the physical effects of the disease, but by psychological and social factors.Impairments and disabilities can worsen with time if no intervention is done. It may lead to further deterioration due to immobility or reduced activity, leading to complications such as thrombus formation, decubitus ulcers, and pulmonary embolism. Patients may also become more dependent on others and have decreased normal social interactions. All of these can have a profound effect on a person’s well-being. Backe, Larsson, and Fridlund (1996) investigated how patients conceived their life situation during the first week after the onset of stroke. They uncovered deep psychological trauma in the patients, wherein they had feelings of unreality, awareness of a changed role in life, feelings of a changed perception of the body, and feelings of being confused. Patients were also found to have a heightened sense of loss of capability and awareness of living in a confined space. Fortunately, some patients also developed an appreciation for the importance of support and encouragement and a will to look for new opportunities after the onset of stroke. One of the important debilitating effects of stroke is immobility. ... It also discusses the role of nurses in the management of stroke patients and in rehabilitation programs. It concludes with learnings from the literature review and critical appraisal and recommendations on how to apply these to nursing practice. The Importance of Movement and Positioning Stroke as a disease process can be progressive. Even though the cerebrovascular event that leads to the neurologic deficits is acute, its sequelae can continue to build on each other, leading to progressive deterioration of the patient. One important example of this is immobility. Due to neurologic deficits, a patient may have difficulty moving. This can lead to development of contractures, muscle atrophy, and nerve palsies (Summers et al., 2009). Current practice advocates early mobility for stroke patients. Summers et al. (2009), in their statements regarding the comprehensive care of the acute stroke patient, recommends that stroke patients may be initially kept on bed rest but should be mobilize d once hemodynamically stable. It has been found that early mobilization reduces the risk of atelectasis, pneumonia, DVT, and pulmonary embolism. Aside from early immobilization, a longer term rehabilitation program has also been found to be effective in stroke patients. Ernst (1990) reviewed the literature on rehabilitation and physiotherapy among stroke patients and found that it was associated with improvement in functional status and lower incidence of secondary complications such as pneumonia and ulcers. Furthermore, Gordon et al. (2004) found in their review of literature that aerobic exercise can enable activities of daily living to be performed

Monday, September 23, 2019

Understanding values Assignment Example | Topics and Well Written Essays - 250 words

Understanding values - Assignment Example An evidence of this is the fact that although people differ on their opinions on a subject, their understanding of what is right or wrong is mostly the same. For example, some people are in favor of legalization of drugs while others are against it, though people on both sides of the argument mutually think that drugs and their influence on the society should be reduced. Even the argument for the legalization of drugs is made with a view to suppressing the frustration and the development and functioning of illegal channels that happens when the drugs are illegalized. The in-born ability, conscience is the word used for which, is guided or influenced by a range of external influences, typically culture and religion. Of all such factors, religion is the most powerful factor that confirms or denies an idea that is considered righteous by our inherent conscience. That is why â€Å"Christianity has often been associated with authority† (11) However, it is needless to say that people voluntarily accept religion and give it that exalted status to dictate values in their lives because of the emotional appeal made to them by the religion. Dictating and establishing values is one of the most fundamental functions of a

Sunday, September 22, 2019

Principles of Public International Law Essay Example for Free

Principles of Public International Law Essay â€Å"Law will never really play an effective part in international relations until it can annex to its own sphere some of the matters which at present lie within the domestic jurisdiction of the several states. † Discuss ‘The principles and regulations established in a community by some authority and applicable to its people, whether in the form of legislation or of custom and policies recognised’. The aforementioned is a definition of law as defined by the American Heritage dictionary of the English Language. If we apply this definition of community in its strictest sense it becomes increasingly difficult to subscribe to the view that there is an international community at large. If we begin to analyse statistics that show that there are over 7000 languages in the world, approximately 10,000 distinctly different religions, and a disputably infinite number of ethnic groups across just the 195 countries that comprise our global society, then it becomes patently clear that we would be better off highlighting our divisiveness rather than our prospects as a global community. Our collective history as human beings, however, tells a different story about our common interest and the way in which we have formally raised and torn down barriers to promote the same. We have, on the other hand, been separated on the basis of differing ideologies and the exercise of exclusive nationalism. Since the latter is a sentiment which resides in particular nations which have at their core a set legal framework validating their very existence and their interaction with other nations, it is essential to any study of law’s application to international relations. How does a sovereign nation reconcile its very sovereignty with its growing need to be integrated into a shrinking global society with its concomitant shrinking global economy? It is clear that some compromises must be made. Before we consider any specific cases in which states have decided to relinquish some of their sovereign power, we must consider the implications of the term sovereignty itself, the elements of sovereignty and its importance to a nation-state. Much has been written on the topic of sovereignty. Definitions vary slightly from one text to the other but they all have at their core, when specifically referring to the idea of state sovereignty, the idea of legitimate authority. In Sohail H. Hashmi’s discourse on sovereignty in the book ‘State Sovereignty, Change and Resistance in International Relations’, he asserts, referring to the concept of legitimate authority, that it is â€Å" a broad concept – not a definition but a wide category – that unites most of sovereignty’s tradition. He further notes that authority can be defined as â€Å"The right to command and correlatively, the right to be obeyed† and is only legitimate â€Å"when it is seen as right by those living under it. † It is to be noted that legitimate authority is not simply the idea of more power. R. P. Wolf, the twentieth century political philosopher and individual anarchist, illustrates the difference more sharply in a classical example in which he argues â€Å"if I am forced at gunpoint to hand over my money, I am subject to power; if I pay my taxes even though I think I can cheat I am recognizing legitimate authority. † We must recognize, however, that though legitimate authority is the overarching principle on any discourse on state sovereignty, there are specific elements of state sovereignty that are crucial, which every sovereign state holds dear to it and attempts to retain regardless of seemingly necessary or stipulated concessions of power, influence or authority to the international community. They include International Legal Validation (of a sovereign state), Interdependence Sovereignty and Domestic Sovereignty. International Legal Validation can be viewed as the right of the state to be a sovereign entity as prescribed by ‘international law’. It is legitimate authority as a legal construct or as Hashami puts it â€Å"legitimate authority† that is â€Å"prescribed by the law. † (Hashami, pg 18) The author Stephen D. Krasner in his book ‘Sovereignty, Organised Hypocrisy’ describes this element of sovereignty as international legal sovereignty. He states that it â€Å"refers to the practices associated with mutual recognition, usually between territorial entities that have formal juridical independence. † At its core international legal validation concerns issues of the recognition of states. If one were ignorant about the political climate on the global front, the natural answer to the question ‘how did a state become a state? ’ would be that ‘the would-be state must satisfy the defined stipulations (in international law) for becoming a state. Following this line of reasoning would inevitably lead one to the very first article of the Montevideo Convention on Rights and Duties of States, which since 1933 set out that â€Å"The state, as a person of international law should possess the following qualifications: (a) permanent population; (b) a defined territory; (c) government; and (d) capacity to enter into relations with other states. It does not take much political savvy, however, to understand that the legal criteria for statehood and the actual criteria for being recognized as a state by the international community at large is a de facto and de jure issue. As Krasner postulates â€Å"States have recognized other governments even when they did not h ave control over their claimed territory, such as the German and Italian recognition of the Franco regime in 1936, and the American recognition of the Lon Nol government in Cambodia in 1970. States have continued to recognize governments which have lost power, including Mexican recognition of the Spanish republican regime of 1977, and recognition of the Chinese Nationalist regime by all of the major Western powers until the 1970s. States have refused to recognize new governments even when they have established effective control, such as the British refusal to recognize the July monarch in France until 1832, the US refusal to recognise the Soviet regime until 1934. (Krasner, pg 15) The recognition of states is definitely an area in which the law (as prescribed by the Montevideo Convention and more recently the EU, which has almost identical tenets concerning the recognition of states) has proved ineffective in international relations precisely because of the political agendas and consequently domestic jurisdiction of the several states which reflect the political climate in which they operate. States attempt to hold on to this type of sovereignty because it affords them clout and validation in a global society in which interdependence is not just an ideal but a tool for survival, at the very least and a necessary aid to prosperity at the very most. The point here is not that nonrecognition brings with it a form of absolute isolation which renders the unrecognised state permanently barred from international commerce and diplomatic relations. What is of paramount importance, however, is the fact that nonrecognition brings with it an air of uncertainty concerning the unrecognised state, particularly in the eyes of multinational firms which as a result may be more reluctant to invest. Krasner notes that â€Å"by facilitating accords, international legal sovereignty offers the possibility for rulers to secure external resources that can enhance their ability to stay in power and promote the security, economic, and ideational interest of their constituents. (Krasner, pg 17) Interdependence sovereignty is the ability of a state to regulate the flow of information, goods, ideas and people into and out of its country. States try to hold on to this type of sovereignty because their ability to do this is directly related to their ability to effectively take control and organise their own polity, which in essence is domestic sovereignty which states must hold on to by definition i. e. in order to be a state in the first place. We shall consider reasons which prompt states to relinquish some of their sovereignty later in our discussion. We have thus far acknowledged, via several examples, based on the politics involved in the process of mutual recognition of states, that the issue of international legal sovereignty or international legal validation is a de facto versus de jure consideration. Is this, however, a trend in the legal procedures in international relations? The law, based on our previously defined definition, must be applicable to the actors in the community in hich it is operating. If, in the realm of international relations, the law can be voluntarily and regularly flouted by those who come under its subjection then serious questions arise about the very existence of ‘international law’. It must be duly noted though that states undeniably operate within the workings of a law order which to a large extent regulates their day to day interactions with one another and which is autonomo us in its operations. There are a countless number of international treatises that are steadfastly observed on a day to day basis. Examples include international agreements which facilitate the smooth to and fro transport of letters which are transported to all corners of the globe at fixed rates which are stipulated by the Universal postal union, the establishment of hundreds of football leagues worldwide- the individual countries who oversee them all subscribing to the specific rules and regulation set out by the world governing body in football, F. I. F. A. and the Vienna Convention on Diplomatic Relations which afford diplomats exemption from prosecution within the courts of the country in which they are stationed. It is evident then that there is a legal framework that regulates the goings on of international relations. We have to probe a bit deeper into the workings of this system in order to ascertain whether or not it can accurately be characterised as international law. It can be argued that upon examination of our above examples of situations in which law plays an effective role in international relations, that the circumstances demand that such broad and far-reaching legal action be undertaken. The methods may vary but in order for letters to be transported globally there must be some standardisation procedure. This sort of necessary ‘self-coercion’ can be observed in a slightly different manner in the operations of international trade and commerce. Often times when two countries have a trade dispute they seek to resolve it in the World Trade Organisation (W. T. O. ), the foremost international authority on trade and trade disputes. The country that loses the dispute, in a legal case which is heard before a court of law under the auspices of the W. T. O. , more often that not abides by the decision. This, again, is not necessarily because the losing party has a great respect or reverence for ‘international law’ or the W. T. O. per se, but rather because it is within its interest to do so. As Harris explains, â€Å"The great majority of the rules of international law are generally observed by all nations without actual compulsion, for it is generally in the interest of all nations concerned to honour their obligations under international law. † (Harris pg 8) He further argues that a nation will be â€Å"reluctant to disregard its obligations under a commercial treaty, since the benefits that it expects from the execution of the treaty by the other contracting parties are complimentary to those anticipated by the latter. It may thus stand to loose more than it would gain by not fulfilling its part in the bargain. This is particularly so in the long run since a nation that has the reputation of reneging on its commercial obligations will find it hard to conclude commercial treaties beneficially to itself. † (Harris pg8) There is, evidently then, a law amongst nations, which is effective regardless of the reason for it being so. The problem of defining this law amongst nations as ‘international law’, however, lies in part because of those very cases in which it is flagrantly disregarded. For any legal system to functional optimally it must operate in a community in which there is a legislative system to make laws as it sees fit, a judiciary to implement the administration of justice and an executive body to enforce the law. Now grant it, generally speaking, there is no formal legislative system in international relations, when countries enter into agreements with each other the signing of treaties is usually undertaken and this serves as the source of law that is meant to dictate the terms of their agreement. However, unlike what is the case in municipal law, there is no definite enforceability method. There is no one authority that can guarantee the compliance of states to international treaties or conventions. We have already made the point that in most cases compliance has become second nature – but what of the cases (though they are scarce) in which it is not? Within the domestic law arena there are cases in which the law is glaringly broken. Once there is enough evidence to convict the wrongdoer, he is convicted and punished. The punitive measures that are undertaken would have been pre-determined by the legislative body and subsequently enforced by an executive body. There is no such arrangement in the international domain. As Harris puts forward â€Å"The problem of enforcement becomes acute, however, in that minority of important and generally spectacular cases, particularly important in the context of our discussion, in which compliance with international law and its enforcement have a direct bearing on the relative power of the nations concerned. In those cases†¦considerations of power rather than of law determine compliance and enforcement. † (Harris, pg 9) Therein lies the difficulty in saying that there is a law of nations. Having established the problematic nature of ‘international law’ or a ‘law of nations’, we shall henceforth temporarily ignore our challenges with nomenclature for the purposes of our remaining discussion. That being said, it is of critical importance to analyse the impact of international law on municipal law and vice versa. There is an ongoing dispute between theorist who believe that international law and municipal law are two separate legal orders and theorist who believe that they are part of the same legal order. The formative argument is known as dualism while the latter is known as monism. There is no one argument based on either monism or dualism that comprehensively settles the dispute. â€Å"On the international plane, international law is invoked and applied on a daily basis by states and intergovernmental organisations. With minor exceptions, it is the only law that applies to the conduct of states and international organisations in their relations with one another. Here international law is a distinct legal system, comparable in its scope and function to a national legal system. † (Buergenthal-Murphy, pg 3) The point mentioned above is very valid and gives credence to the dualism argument. Diplomatic relations, as discussed earlier, are dealt with strictly on the international plane. In order to see the appeal of the monism argument however we have to look no further than the argument establishing the Caribbean Court of Justice (C. C. J. ). Article XXIII of this agreement is as follows: 1)Each contracting party should, to the maximum extent possible, encourage and facilitate the use of arbitration and other means of alternative dispute resolution for the settlement of international commercial disputes. )To this end, each contracting party shall provide appropriate procedures to ensure observance of agreements to arbitrate and for the recognition and enforcement of arbitral award in such disputes. The C. C. J. is a court whose aim is to have a â€Å"determinative role in the further development of Caribbean jurisprudence through the juridical process† is thus an international lega l authority. In order for its smooth operation it must nevertheless depend on the domestic jurisdictions of its member states. Monism and dualism can hence be viewed as fluid concepts which exist in varying degrees.

Saturday, September 21, 2019

The Sonyericsson Alliance Essay Example for Free

The Sonyericsson Alliance Essay In 2001, the mobile phone terminal market world was shaken by the announcement of the agreement between two  « giants  » of their respective worlds. On one side the telecommunication reference Ericsson, on the other the entertainment and communications company Sony. As the result of the strategic alliance, an agreement focused on their respective mobile phone terminals businesses bringing to life a new joint venture aiming to gain consistent market shares during the next five years of operations. In this analysis I will start from an introduction of the respective companies, a short overview of their market positioning and a brief historical overview of the birth of their joint venture. Further on I will use the tools taken from (Jolly, 2001) to analyze the conditions and strategic management (steering) of this alliance. 1. Introduction 1.1 About the partners Ericsson : Ericsson, a Swedish based company, is the world-leading supplier in telecommunications systems with the largest customer base, including the worlds top 10 operators. The company provides total solutions covering the whole range, from systems and applications to mobile phones and other communications tools. Ericsson has been active worldwide for over 1 century and today operates in more than 140 countries, with 95,000 employees based in 24 countries. Annual investments in technical development average 15 percent of sales. These investments contribute to Ericssons leadership in mobile infrastructure and mobile Internet, with nearly twice the size of the closest competitor. Four out of every 10 mobile calls are handled by Ericsson equipment. Ericsson has a strong focus on RD and has filed 1,300 patent applications filed during 2000. Ericsson has set several standards to the mobile communication market, like CDMA2000, WCDMA or Bluetooth technology (see Appendix 1). Ericsson is thus the world leader in broadband technology.2/2 Ericsson supplies operators and service providers around the world with  end-to-end solutions in mobile and broadband Internet. Ericsson supplies solutions for all existing mobile systems, including future 3G mobile systems, as well as broadband multi-service networks and broadband access. The solutions include network infrastructure, access equipment and terminals, application enablers and global services to support both business and private communications. (For details see : www.ericsson.com) Ericsson achieved Net sales of 31 bUSD in 2001, but achieved a negative Net Income of -2.8 bUSD. (Financial Report 2001, Ericsson) Sony Founded in 1946 as Tokyo Tsushin Kenkyujo (Tokyo Telecommunications Laboratory) by Mr. Ibuka , Sony has become the world-leading manufacturer of audio, video, games, communications and information technology products for personal and professional market. Sony has set several standards to the consumer electronics market and driven technology development (see Table 1).

Friday, September 20, 2019

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

Thursday, September 19, 2019

Essay --

Imagine yourself for a day without being capable of communicate or understand your surroundings. In my opinion communication is the key for success in every stage of our life. My research is based in reference of disabilities associates with communication disorder in children and adults. As I can conclude the explanation of communication is when a person is able to exchange feeling, knowledge and desires with others. It can be expressed in different ways one is verbal and the other non-verbal. Language in other ways is as well important part of human communication system. It control and intervene our actions, thoughts, and behaviors. even though language and speech are sometimes inseparable they are different. I learned from the class and from my personal study that communication is essential for human development. It begins at birth and develops through life. At birth newborns act in response to involuntary noises in reaction to physical stimulus . Babies learn to communicate with their parent with face expressions and gestures. At 9 months they start imitate sounds of speech from around them. Children begin to vocalize around 18 month and in quick time they learn to speak. The importance of identifying any communication disorder of children is essential for their progress. Some of this disabilities can be diagnosed before the age of 1. Learning to speak give the ability to communicate with the world. A child’s communication is considered delayed when is clearly behind in comparison with others at their same age speech and language skills. Communications problem in some cases is generally present in children with physical impairments including hearing loss, neurological disorders , injury in their brain, mental retardation, dr... ...lso to work in group socializing between them. Some kids need to take individual session depending in their level. The interaction of family in therapies is very important. It will give the children enthusiasm to continue practicing. The importance of therapy is to continue its use in school where children are out of their home. In my opinion it help the learning process because they can try to be like other children and start to communicate with them. Children with communication disorders regularly perform inadequate academic level, having big problems with reading, trouble understanding and express verbal communication, they avoid attending school. If they participate in interactive communication with adults in the instructive situation they may succeed in school. In many cases the use of psychological and psychiatric counseling are consider very important. Essay -- Imagine yourself for a day without being capable of communicate or understand your surroundings. In my opinion communication is the key for success in every stage of our life. My research is based in reference of disabilities associates with communication disorder in children and adults. As I can conclude the explanation of communication is when a person is able to exchange feeling, knowledge and desires with others. It can be expressed in different ways one is verbal and the other non-verbal. Language in other ways is as well important part of human communication system. It control and intervene our actions, thoughts, and behaviors. even though language and speech are sometimes inseparable they are different. I learned from the class and from my personal study that communication is essential for human development. It begins at birth and develops through life. At birth newborns act in response to involuntary noises in reaction to physical stimulus . Babies learn to communicate with their parent with face expressions and gestures. At 9 months they start imitate sounds of speech from around them. Children begin to vocalize around 18 month and in quick time they learn to speak. The importance of identifying any communication disorder of children is essential for their progress. Some of this disabilities can be diagnosed before the age of 1. Learning to speak give the ability to communicate with the world. A child’s communication is considered delayed when is clearly behind in comparison with others at their same age speech and language skills. Communications problem in some cases is generally present in children with physical impairments including hearing loss, neurological disorders , injury in their brain, mental retardation, dr... ...lso to work in group socializing between them. Some kids need to take individual session depending in their level. The interaction of family in therapies is very important. It will give the children enthusiasm to continue practicing. The importance of therapy is to continue its use in school where children are out of their home. In my opinion it help the learning process because they can try to be like other children and start to communicate with them. Children with communication disorders regularly perform inadequate academic level, having big problems with reading, trouble understanding and express verbal communication, they avoid attending school. If they participate in interactive communication with adults in the instructive situation they may succeed in school. In many cases the use of psychological and psychiatric counseling are consider very important.

Wednesday, September 18, 2019

Descartes’ Cogito Essay -- Philosophy small universal elements

Descartes’ Cogito It is the purpose of this essay to examine both Descartes’ Cogito argument and his skepticism towards small and universal elements, as well as the implications these arguments have on each other. First, I will summarize and explain the skepticism Descartes’ brings to bear on small and universal elements in his first meditation. Second, I will summarize and explain the Cogito argument, Descartes’ famous â€Å"I think, therefore I am† (it should be noted that this famous implication is not actually something ever said or written by Descartes, but instead, an implication taken from his argument for his own existence). Third, I will critique the line of reasoning underlying these arguments. Descartes attacks small and universal elements with the problem posed by the possibility of God being an omnipotent deceiver, but he seems to think his Cogito argument is immune from this type of criticism. Fourth, I will show how the Cogito is actually har der to establish than the existence of small and universal elements. And, fifth, I will establish small and universal elements as an Archimedean point (i.e. – a foundational claim). In Descartes’ first meditation, paragraphs 9-12, he arrives at the final and most devastating stage of questioning his beliefs. In his first two stages, he questions both small and distant objects and medium sized objects, and concludes that neither can be held as true with any certainty. He throws out the first because of the possibility that the small and distant object is a mirage, and throws out the second because of the possibility that we are actually dreaming while perceiving medium sized objects. In his third and final stage of doubt, Descartes’ examines sma... ...things. The lack of an omnipotent deceiver and the reality of the existence of small and universal elements lead to an even broader foundational claim; there is a world where the small and universal elements exist. Either it is the world around us at his very moment, or, if this is a dream, it is the world of the dreamer whose small and universal elements make up this dream world. In concluding, a few things must be noted. One, Descartes’ omnipotent deceiver does not and cannot exist in the manner Descartes relates. Two, even if the deceiver did exist, the Cogito would not be immune from the pall of doubt the deceiver’s existence would cause to fall on reality. Three, even without the deceiver, the Cogito is falsifiable because of the â€Å"Someone Else’s Dream† argument. Four, there is a world where small and universal elements we know of exist.

Tuesday, September 17, 2019

Financial Analysis of Honest Tea Essay

Through Honest Tea’s three years of business, their business shows some positive signs of a promising company. Since Honest Tea is a start-up company, it is understandable that their net income is in the negatives since their expenses will outweigh their sales, but as the three years have gone on, their net income has improved, and even increased by 74% from 1999 to 2000 from -$882,359 to -$228,879, which shows a positive sign of growth. Honest Tea is also very capable to pay back their short term liabilities since their current ratio is a high 5.92. Their profit margin has also increased over the three year period from -71.7% to -36.3% showing positive signs of profit and ability to grow. Honest Tea is able to generate $0.50 for every dollar of assets they have, which isn’t a huge amount, but being in the positive for a start-up company is important. Unfortunately, Honest Tea isn’t very efficient in turning over its inventory since this turnover ratio is less than one, but, for a start up, they are doing well. Revenues increased tremendously from 1998 to 1999, but fell by almost 50% in 2000, so that is worrisome. The debt to equity ratio in 1999 was .241 and it decreased in 2000 to .142. A lower debt to equity ratio usually implies a more financially stable business, so it’s great that the debt to equity decreased from 1999 to 2000. Companies with a higher debt to equity ratio are considered more risky to creditors and investors than companies with a lower ratio. Unlike equity financing, debt must be repaid to the lender and requires debt servicing or regular interest payments. In other words, debt can be a far more expensive form of financing than equity financing. Companies leveraging large amounts of debt might not be able to make the payments. Creditors view a higher debt to equity ratio as risky because it shows that the investors haven’t funded the operations as much as creditors have, so it’s good to see that Honest Tea has been getting more money from investors so they don’t have a large amount of debt. Compared to some other companies in their industry (Triarc Cos Inc, Saratoga  Beverage, National Beverage Corp., Clearly Canadian Beverage, etc.), Honest Tea is far behind. Most of this is due to the fact that Honest Tea is a start-up company and all of these other companies are well established, but these competitors are turning out positive profit margins and positive net incomes which makes it very hard for Honest Tea to compete in the market. 1.) Honest Tea’s sales dropped in 2000, so they are trying to find more capital to keep the company running. The success of the company, before the cold spell in 2000, had drawn a lot of media attention which caused Honest Tea to be featured in Fortune, Entrepreneur, and Beverage World, which definitely helps the company’s reputation, but Honest Tea really needs to get their sales back going in order to stay relevant in the market. 2.) First of all, in the future, Honest Tea need to raise more financing to be successful. They need to find more venture capitalists or angel group in order to support the continuation of the company. Honest Tea also needs to start expanding distribution of their product, but that can only happen if they get the financing to pay for the distribution. They need more distribution so they can pick up more customers that will demand their product, in hopes that either they can grow Honest Tea as its own company, or that it will get picked up as part of another big brand such as Pepsi or Coca Cola. 3.) In order to continue its distribution and growing the company, Honest Tea believes a $2 million round of financing would carry Honest Tea to profitability. 4.) Honest Tea has received financing from many different places. The first financing had come from Goldman and Nalebuff, they would be decent investors but they only have so much money to give to the company. Next, they approached family and friends, they raised around $200,000 for Honest Tea but they wouldn’t be considered the ideal investor because they don’t have enough money to support Honest Tea past their seed stage. Customers of their product have also contributed capital to the company, but these investors have not been the right investors because they are not as sophisticated as  venture capitalists and angels, and don’t necessarily have the experience with interpreting financial statements which means they require a lot of extra time and attention and that takes away from Goldman and Nalebuff’s ability to focus on growing Honest Tea. They also received financing from venture capital groups, which would be a better fit for Honest Tea since the venture groups don’t need as much attention as Honest Tea’s other unexperienced investors but they also demand more control of the company than Honest Tea’s other investors. 5.) Right away with the financing from the family and friends, there wasn’t really a specific structure, but in 1998 Honest Tea established a financing structure. The financings have been structured so that when an investor purchased common stock, the founders were given warrants for creating the company. Honest Tea structured them in this way because Nalebuff though that by including warrants for the founders with exercise prices staged at multiples of the initial price at which family and friends brought in would avoid such disagreements. If the company did well, then they would be able to exercise their warrants and they would own a greater fraction of the company, but if they didn’t, then the original investors would own a larger piece of the firm. 6.) Honest Tea should look for angel investors or venture capitalists, this is because the investors that Honest Tea currently has are very inexperienced when it comes to financial statements, so to have financiers that have experience and knowledge when it comes to investing and finance. Angel investors and venture capitalists also have more access to large amounts of capital and have connections that the current investors do not. 7.) The proposed financing and valuation do make sense because it gives Honest Tea the best chance of the founders maintaining 50% of the equity of the company. Honest Tea is using a warrant based structure, which seems complex, but really it’s a smart way to structure their financing. This type of financing allows Honest Tea to keep founder equity, as long as they meet their goals and targets. If they don’t, more of the equity goes to their investors because they will be issued more shares of the company. This is a  good set-up because it gives Honest Tea’s owners a reason to work hard to meet their goals, and if they don’t the founders will lose their 50% share of the company. The valuation of the company makes sense because it’s based on Honest Tea’s sales of their two products and the value of their bottling plant. If they sell a lot of their products, the valuation of their company goes up. However, if they don’t sell enough of their product, the valuation of the company goes down. If the valuation goes below $15.1 million, then shareholders will be issued more shares and they would get more control over the company. 8.) The ready to drink tea market is looking very promising for Honest Tea. In 1999, the ready to drink tea market totaled $2.67 billion, which was an increase by 9% from 1998. Although this doesn’t seem like a huge market, because the wholesale and retail sales have increased by 9% in just one year, I believe that the market will grow. Experts even projected that the read to drink tea market would more than double in size over the next 10 years, meaning the $2.67 billion market will be an over $5 billion market in a short 10 years. Distribution channels have also been growing, ready to drink tea sales and loose tea bag sales have been growing in other channels such as drug stores, and growing by 21.2% growth in volume sales in mass merchandise, which is outgrowing other forms of drinks such as coffee and bottled juice. Honest Tea’s competitors are national brands; Snapple controls 14.6% of the market, Arizona Iced Tea holds 10.6% of the market, and Lipton represents 9.5% of the market. Honest Tea’s competition/ brand loyalty would be considered one of the barriers to entry; all of Honest Tea’s competition is well established national companies, which means that it would be very hard to compete with them since they have already mastered their distribution around the country and they all have significant control of the ready to drink tea market. Economies of scale is another barrier to entry for Honest Tea, since other companies in the market has a lot of production their average costs fall, but since Honest Tea is a small company their average costs are still large, so they need to work to increase their production to get their average costs down. 9.) Rapid growth is not that important, especially if it causes Honest Tea to  compromise some of their convictions. It would be more beneficial for the company to grow slowly and organically to keep the mission of their company. If a venture capitalist pushes Honest Tea to grow too fast, this may cause Honest Tea to take shortcuts when it comes to being organic and environmentally and economically responsible, which could cause customers to not value the Honest Tea brand as they did when they were growing slowly. So I would say that rapid growth is not important to Honest Tea. However, going national is very important for Honest Tea. Honest Tea needs to go national in order to get brand loyalty, so grocery stores, gas stations, dining establishments, etc., would demand to have Honest Tea in their establishment. Going national would also mean that Honest Tea would have better access to investments or a chance to be acquired by a strategic partner, which is part of Honest Tea’s exit strategy. So going national is a huge part of what Honest Tea wants to accomplish with its company, which means it’s very important to go national. 10.) Honest Tea needs the money for investing in new distribution channels, hiring a nation sales force, purchasing marketing and merchandising materials, gaining capital to support the launch of Honest Tea in new super market chains, and gaining capital to get the Three Rivers Bottling plant to profitability. They need the money as soon as possible because it need to cover operating losses for the next several quarters to keep Honest Tea functioning. 11.) The pro forma projections of Honest Tea do make sense. The pro forma projections take into account the months that ready to drink tea sales may decline due to seasonal preferences, for example since January and February aren’t a time where the market would demand a cold, refreshing drink, Honest Tea has projected those months to have the smallest amount of cases sold. Conversely, the projections also show that the tea bag sales will increase when ready to drink tea decreases. Honest Tea’s projections make sense in the aspect that they take into account the coolers, marketing, travel expenses, etc., that will come with expanding their business. The projections also show how the expenses per month decrease showing that the company is taking economies of scale into consideration, meaning that the  more production they have the average cost will decrease. One aspect of the projections that don’t make sense is how the end of 2001 the company’s net income is in the positive, but once January of 2002 begins, Honest Tea is projecting a huge drop in net income to -$286.1, but besides that, Honest Tea’s projections make sense. 12.) Honest Tea’s financing strategies thus far have not been ideal. They have depended on family, friends, and customers to provide them with capital, and this has caused Seth and Barry to spend much of their time explaining financial statements, searching for more capital, and holding the hands of their inexperienced investors. The current financing has caused Seth and Barry to spend too much time worrying about investments, and not enough time to figure out how to grow the business. Seth and Barry really need to start looking for more professional sources of financing such as angels and venture capitalists.The valuation and financing structure that Seth and Barry have set up for the offering of their shares have provided Honest Tea with a much more organized and reliable financial structure that allows them to not have to spend so much time explaining themselves, which gives them more time to grow their business. 13.) This deal is very attractive to venture capitalists. Honest Tea has a huge market opportunity since they have created a new beverage category that has been on the rise the past couple of years, which would be very attractive to an investor. Honest Tea has also proved that customers are willing to buy their product and even invest in it, which shows they have a following. Another reason this deal is very attractive, is that Honest Tea has received much media attention and received different awards for sustainable practices and packaging, so the product is well known and has the potential to have brand loyalty in the future. Honest Tea also has great management teams that have expertise in the tea industry, and have even worked for companies, such as Sobe, who have rapidly expanded in the past. A great management team is very appealing for a venture capitalist because it means that the VC has to spend less time watching over the company since they already have the expertise that they need to grow. Lastly, Honest Tea is a great venture capital investment because it already has access to its  own bottling plant, so they have no barriers when it comes to mass production. Their bottling plant has the opportunity to provide Honest Tea with approximately $30 million in sales, which is very attractive for an investor. 14.) The deal with the venture capitalist is not attractive for Seth and Barry. First of all, the deal wanted the pre-money valuation of the company to be $5-$7 million, which means that the founders have to give up their proposed 50% control of the company. Secondly, the rapid growth that the venture capitalist is pushing may require Honest Tea to compromise on some of its more socially conscious principles. Currently, Honest Tea is structured so that the founders have the control of the company, so they can do what they like, but giving up half of their control would most likely mean compromising their principles. Even though the $5 million investment would help Honest Tea tremendously, it isn’t worth sacrificing their principles to grow quickly. Honest Tea should consider the Investors’ Circle investment over the venture capitalists. Even though Investors’ Circle isn’t offering as much money as the VC, their principles match Honest Tea’s principles. Investors’ Circle invests in socially responsible start-ups, so they won’t push Honest Tea to compromise their principles, instead, they would support their principles. Investors’ Circle is even willing to invest up to $6.5 million depending on the company’s needs, so Honest Tea should really consider getting an investment from Investors’ Circle over the venture capitalist. 15.) The deal structure and valuation make sense, but it’s hard to know what they based the pre money valuation on since it’s very low compared to Honest Tea’s valuation. The deal structure does make sense, since the venture capitalist is giving Honest Tea so much in financing it makes sense that they would require significant control over the company.

Monday, September 16, 2019

Principles and Values of working with young children Essay

Principles 1. The welfare of the child is paramount. Within my role I have to support children and help them achieve their goals, from tying their shoe laces to providing skills to help young people to live in the community. I have to make sure all staff promotes a warm, caring, supportive, positive and tolerant atmosphere. This is to help work on raising the child’s self-esteem, self-confidence and self-worth. I have to be very creative in my role at a moment’s notice, adapting to different situations. It is essential that I have excellent communication skills when interacting with children, teachers, parents, social workers, police etc. I must show empathy, and make sure i am aware at all times of confidentiality 2. Practitioners contribute to children’s care, learning and development and this is reflected in every aspect of practice and service provision. Organise residential activities, onsite and offsite (making sure the risk assessment in complete) Carry out domestic duties, and encourage children to be independent by guiding and showing children domestic duties i.e. making beds, tidying their room Ensure you guide children to ensure they have a regular hygienic routine At all times, make sure the children’s individual primary social emotional and physical needs are met Assist with the breakfast and evening meals supervision and process, making sure they have a balanced diet, and are aware of the importance of a balanced diet Support children’s social and life skills including personal hygiene, social behaviour and independence. Key worker for individual children – Assist in assessments of pupil needs and  maintain pupil care plans and records. Contribute to annual reports and reviews and any other relevant procedure. Meet with Key child on a weekly basis to carry out support sessions, this enables us to address specific issues the child may have Identify specific pieces of work to look at with key child i.e. self-esteem work anger management strategies Ensure essential information file is up to date Ensure key child’s views are fully recorded Health requirements are to be fully up to date with any changes in medication or time of taking dosage etc. Plan and agree individual targets with key child (reward charts) 3. Practitioners work with parents and families who are partners in the care, learning and development of their children and are the child’s first and most enduring educators Promote effective communication between the school, children and their carer’s and ensure that children and their careers are involved with or are aware of children’s targets, complaints and other procedures Create and maintain a positive line of communication with parents Attend meetings where appropriate Produce reports on incidents, concerns etc. and communicate effectively as necessary. I.e. Child in Need Meeting Complete a daily log for every shift detailing how the child has spent there day noting: positive behaviour, negative behaviour, health, hygiene, what activities they have taken part in and diet. Values 1. The needs, rights and views of the child are at the centre of all practice and provision. On admission, each child is schooled for a period of time in the class room. During this time an in depth assessment of academic ability, social skills and behaviour is carried out. This is using a ‘boxhall profile’ which includes behavioural, work and social needs will be programmed specifically to the child’s needs. A keyworker is assigned to an individual child, so we can spend time with the individual child and find  out their needs etc This can be just spending time with a child playing football, or an organised support session, where we take them out of the building, maybe for a hot chocolate. All information is recorded and passed on to the relevant people, if needed. 2. Individuality, difference and diversity are valued and celebrated. At our setting when a child starts at our setting, we have a ‘care plan’ that we go through (A copy has been sent for evidence). This includes the following: Young person background Family contact Equality, diversity, culture, religion, language and race Communication – how they like to communicate Health Identity, self-awareness and emotional well being Mealtimes Hygiene, including bedtime and waking up routine Behaviour – how they view their behaviour and how we can help them Activities – What they would like to try Independence – There goals and what they would like to achieve Transition Plan – How they would like to move on, and what they feel is best for them Each Keyworker is assigned to get to know that individual child, this could be by creating the care plan, support sessions and activities. Each child is encouraged to thrive in what they are interested in, and try new things. If a child celebrates a certain religion, then we would always accommodate them in their beliefs. This could be in a casual way, either over dinner: where they would help make a dinner of their choice, or an outing that would show us how they celebrate their religion. When a child celebrates a birthday, we organise a birthday cake of their choice, and they have a present which is presented to them with everybody present. 3. Equality of opportunity and anti-discriminatory practice are actively promoted. We do not discriminate against staff or pupils on the grounds of their gender, disability, race, religion or belief, nationality, ethnicity or national origins, sexual orientation, gender reassignment, pregnancy or  maternity. This is in line with the Public Sector Equality Duty from the Equality Act 2010 and covers both direct and indirect discrimination. We promote the principles of fairness and justice for all through the education that we provide in our setting.  Through positive educational experiences and support for each individual’s point of view, we aim to promote positive social attitudes and respect for all. Our school aim is to tackle discrimination and promote equality of opportunity and good relations across all aspects of school life. We do this by: Creating an ethos in which pupils and staff feel valued and secure; Building self-esteem and confidence in our pupils, so that they can then use these qualities to influence their own relationships with others; Having consistent expectations of pupils and their learning; Removing or minimizing barriers to learning, so that all pupils can achieve; Actively tackling discrimination and promoting racial equality Regular consultation with parents/carers and members of the local community, so that they are well informed of our policy and procedures; Making clear to our pupils what constitutes aggressive and prejudiced behaviour; Identifying clear procedures for dealing quickly with incidents of prejudiced behaviour; Making pupils and staff confident to challenge prejudiced and aggressive behaviour We do not tolerate any forms of discriminatory behaviour including direct or indirect discrimination, harassment or victimisation. Should an incident occur, we will act immediately to prevent any repetition of the incident and do all we can to support that person in overcoming any difficulties they may have. Incidents are logged on our online ‘sleuth’ system. Incidents could take the form of physical assault, verbal abuse, and damage to a pupil’s property. Any adult witnessing an incident or being informed about an incident must follow these agreed procedures: Stop the incident and comfort the pupil who is the victim Reprimand the aggressor and inform the victim what action has been taken If  the incident is witnessed by other pupils, tell them why it is wrong Report the incident to the headteacher or a member of SMT and inform him/her of the action taken. This should be logged on sleuth, and parents contacted Inform the class teacher and Head of Care, of both the victim and the aggressor 4. Children’s health and well-being are actively promoted. Children’s physical and emotional and social development needs are promoted. This is via our ‘care plan’ and organised support sessions. Children are constantly advised how to understand their health needs, how to maintain a healthy lifestyle and to be independent, and look after their bodies. Children are encouraged to participate in a range of positive activities that contribute to their physical and emotional health. If a child is unwell, then they would generally go back home to their parents or carer, but if they can’t then we access the local doctors and other health professionals. Children’s health is promoted in accordance with their care plan and staff are clear about what responsibilities and decisions are delegated to them. If a child needs consent for medical treatment, this is issued before the child starts at our setting. Children’s wishes and feelings are sought and taken into account in their care plan. Care staff always receives sufficient training on health and hygiene issues and first aid with particular emphasis on health promotion and communicable diseases. Staffs receive guidance and training to provide appropriate care if looking after children with complex health needs. Our setting has good links with health agencies, including specialist services where appropriate, such as CAMHS and sexual health services. The availability of such services is taken into account when deciding on admissions. 5. Children’s personal and physical safety is safeguarded, whilst allowing for risk and challenge as appropriate While allowing for risk and challenge to the capabilities of the child. It is essential that we protect children from serious harm and injury. However, children must also learn to be independent and should be allowed to explore their environment according to  their age and ability. Within our setting it is everybody’s responsibility to keep the children safe, and the welfare of the child is paramount. We provide a safe environment that allows appropriate risks and challenges i.e., climbing frames. We allow children to take safe risks but always supervised. We always carry out a risk assessment and always follow health and safety rules. 6. Self-esteem, resilience and a positive self-image are recognised as essential to every child’s development. Self-esteem and positive self-image is recognised as an essential part to every child’s development. A child’s self-image is their view of who they are and what they are like. Within my den sessions we work on self-image and do a body map of themselves and we discuss how they feel when they are angry, sad, happy etc. We discuss the different feelings, and work on areas that are concerning them. It is essential to every child’s development that they have high self-esteem and a positive self-image. If they do, they are more resilient and are able to cope well with difficulties in life. Within our setting we always praise children’s efforts and achievements, and show them that they are valued, 7. Confidentiality and agreements about confidential information are respected as appropriate unless a child’s protection and well-being are at stake. Confidentiality and agreements are respected as appropriate unless a child’s protection and well-being are at stake. All staff has a responsibility to maintain confidentiality at all times. Maintaining confidentiality means that any information given to us should only be passed on in the interest of meeting the needs of the child, according to the policies of the setting. The sharing of information among practitioners working with children and families is essential. It is only when information is put together that a child can be seen to be in need or at risk of harm – The Children’s Act are the laws that aim to protect children from harm in any setting. This legislation is based on the principle that all children have the right to be protected. These are written procedures that aim to protect children in all settings. Confidentiality is also governed by the Data protection Act, which states â€Å"The storage, retrieval  and handling of confidential information verbally, written and electronically to protect the rights of the client. It identifies guidelines and practice and when certain information can be passed on; it serves to protect the child from harm. Within our setting all personal files are locked away and access is restricted to relevant people with the permission of parents, unless there are concerns about the child. 8. Professional knowledge, skills and values are shared appropriately in order to enrich the experience of children more widely. Professional knowledge skills and values are shared. Professional knowledge, skills and values are shared between professionals to enhance the experience of children more widely. Working within a team helps us to share profession knowledge, skills and values. This benefits the children and helps us to give the care the child needs. Within our work setting, we have daily handovers, so we completely understand how the last shift went. We have ‘care meetings’ at least once a month. This enables all staff to share relevant information, ideas and suggestions and plans for the month ahead. It also gives us all the opportunity to take suggestions from each other about their experiences of how they have handled certain situations; taken in a positive way, in can improve our own practice. 9. Best practice requires reflection and a continuous search for improvement. As a professional worker you must take responsibility for your own development and performance. Other practitioners can help and guide you towards best practice, but you will only make good professional progress if you become aware of your strengths and weaknesses. You must want to improve your skills and take responsibility for this. You should try to think about, or reflect on what you do, however, we all find it difficult at times to know how good or bad we are at something and to know our strengths and weaknesses. Most people need the help and feedback of others to do this. The most useful feedback will usually come from a Senior, Head of Care or an experienced worker. You should try to listen to others. Think about what they say to you and be open to suggestions about how you can change and improve how you work. During work appraisals is a good time to identify what your professional improvement needs are and to identify available training  that may be needed.