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Application Of Ich Q9 As A Systemic Process For The...

Introduction ICH Q9 (Quality Risk Management-QRM) is a systemic process for the assessment, control, communication and risk review to the quality of the medicinal product. Application of QRM can be done by both proactively and retrospectively. It was adopted by European Union and PIC/S†¡ in Annex 20 of EU and PIC/S GMP guides. In pharmaceutical industry, Quality System is important criteria and QRM is a valuable component of an effective quality system. The QRM should ensure that the evaluation of the quality risk is based on some criteria like knowledge about science, experience with the different process and ultimately links to the protection of patient. It also ensures the effort level, formality and documentation of the QRM process is appropriate with the level of risk. Product quality should be maintained throughout the product lifecycle such that the attributes as it is important to the quality of the drug product which remain consistent with those used in the clinical studies. It can further ensure the quality of drug product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing. It can facilitate better and more informed decisions, and can beneficially affect the extent and level of direct regulatory oversight. Guidance to ICH Q9 provides principles and tools for QRM which can be applied to different aspects of pharmaceutical quality includes development, manufacturing, inspection and

Particular Elements Of Leadership Attained â€Myassignmenthelp.Com

Question: Discuss About The Particular Elements Of Leadership Attained? Answer: Introduction Leadership is a necessity for human success. All aspects of human life require particular elements of leadership to be attained. Despite its popularity, leadership remains a contentious topic to many people. In fact, the real meaning of leadership differs significantly from how many people perceive it. Precisely, I was among the many who did not have a precise comprehension of what leadership entails. However, after undertaking my studies throughout this semester, my perception on what leadership involves have significantly progressed. This reflection exhibits my knowledge development on leadership throughout the semester. It captures my prior understanding of leadership and illustrates how this view has been altered and enhanced by the semester content. Furthermore, the reflection outlines how studies on leadership have impacted on my life and points areas where I need to improve. With the world becoming globalized, it is vital to possess the appropriate leadership competencies. Alt hough the course lasted only of one semester, its contents significantly changed my marketing on leadership and its importance in the society. Reflection Initially, I thought that the term leadership is directly related to authority and power. In fact, I defined a leader an individual who uses coercive means to impose their will on others. I held that leaders are people who hold administrative positions in the society. In this respect, I understood leadership as the ability to impose persons will on their subjects. Furthermore, I believed that leadership is authoritative and cannot be questioned. Out of this view, I assumed that a leader is an individual who is there to be served by others. However, after interacting with course resources, my understanding of leadership and its fundamental elements changed. According to Bertocci (2009), leadership is the combination of attributes or personality traits in an individual that compels them to motivate others to achieve a specific goal. This revelation is completely different from my prior understanding. As the course progressed, I made several deductions on what leadership and a leader entail. Firstly, a leader is an individual who inspires other to achieve a goal. Leadership is about inspiring and motivating other regardless of your position. In this view, everyone one can be a leader in different capacities. For instance, in an organization, even a lowly ranked employee can serve as a leader through their actions. This insight refutes my earlier assumption that only those in high positions in organizations serve as leaders. Secondly, I discovered that leaders are agents of change. For one to be a leader, they must devise new ways of thinking and handling issues. According to Fairhurst and Connaughton (2014), leaders are persons whose actions affect other people more than other peoples acts affect them. The efficiency of influencing others emanates from the increased level of commitment that leader have to initiate change. From this argument, I realized that leadership requires dedication and handwork. In fact, this premise refutes my earlier proposition that leaders exist to be served. Instead, leaders exist to serve and cater to the needs of others. As a leader, one must take up certain obligations to justify their status. Consequently, this opinion illustrates that leadership is not easy as it appears on literature. Importantly, the concept of servant-leadership further elaborates that leaders are not there to give instructions. Instead, it insists that leaders exist to lead the way and inspire other to follow their actions. The concept of servant-leadership posits that all leaders are servants(Northouse, 2012). The servant-leadership concept argument enlightened me that leadership is not all about the use of coercive force and demand for results while sitting in an office. Instead, leaders should lead by example. Moreover, the concept insists that leadership should not be used as a tool for creating class division between the leaders and their servants. In contrast, leadership exists to optimize the interaction between individuals in the society. In this respect, I learned that leaders should be role models to the community. This view implies that leaders should identify with hardships that others are experiencing. Moreover, the course also educated me that leaders influence the motivation of team members through non-coercive means. This understanding transformed my previous perceptions that leaders are authoritative and cannot be challenged. Although leaders command some degree of authority due to their position, this power should not be used to impose ones will on others. In the modern business world, people fear their leader because of the powers invested in them by their organization. However, effective leaders should psychologically utilize these powers to motivate others in goal achievement. Over the years, I struggled to make clear distinctions between leadership and management. In fact, I believed that there is no difference between a manager and a leader. My previous opinions were greatly influenced by the structure of the modern market environment. The way the present society operates, it is difficult to make clear distinctions between a manager and a leader. These two terms are used interchangeably to refer to those who hold a high position in organizations. However, after scrutinizing the semester materials, I realized that significant differences exist between leadership and management. The main difference between these two is that management focuses on planning, organizing, and coordination of activities while leadership emphasizes on inspiring and motivating (Kotter,2008). Out of these key distinctions, I deducted the difference between a leader and a manager. A leader inspires and motivates people to follow them while a manager has individuals working for them. Throughout history, there have been heated debates on whether leaders are made or born. Early scholars like Thomas Carlyle contended that leaders are born. They even went forth to devise frameworks like the great man and trait theories to support their opinion. Before interaction with the course materials, I also held the view that leaders are born. In fact, I backed up my opinion by outlining that renowned leaders possessed certain unique attributes. However, after reading several modern leadership theories from the course materials, I realized that leaders could also be made. According to Dav (2000), leaders one can become a leader by acquiring certain competencies through training. Through training, one can acquire leadership competencies like effective communication, team work, conflict management and decision-making. This view implies that it possible for one to be a leader even if they hail from a family that has not produced renowned leaders in the past. In the contemporary business environment, leaders are defined by the success of their organizations. With clear distinctions lacking between management and leadership in the present society, people have used profitability of firms a yardstick to measure a leaders success. However, I acquired y essential points from the course materials which changed my view on leadership success debate. I learned that there is a direct relationship between leadership success and organizational culture. According to Baumgartner (2009), an organizations culture can limit the effectiveness of a leader. For instance, an organization that lacks a transformative culture can hinder the ability of a leader to initiate change. As an aspiring leader, I learned that it is vital to scrutinize the culture of an organization before joining it. Moreover, I gained insight that leadership is not gendered. In the past years, there have been misconceptions that women cannot make effective leaders. In fact, I also doubted women's ability to lead. My doubts emanated from the reality that majority of popular leaders are men. However, Burke and Collins (2001) disproves such assumptions and assert that any gender can produce leaders. In fact, the economics of successful female leaders like Mary Barra of General Motors confirms the view of Burke and Collins (2001) on the ability of women to lead. This view has made believe that anyone can be a leader when given a chance. In future, I will advocate for equality in leadership positions in my organization. I have realized that it is wrong to presume that men are better leaders than women or vice versa. The learning materials have also exposed me to the essential leadership competencies. Initially, these concepts were not clear. However, as the course progressed they become precise and clear. At the initial stages, the course addressed general features of leadership. But as time progressed and the instructor focused on the specifics, the concepts become apparent. The key leadership competencies like communication, integrity, decision-making and conflict resolution strategies learned throughout course will enable me to develop the essential employability skills. Currently, organizations want employees who are leaders. With these competencies in mind, I can utilize them for employment purposes and personal development. Importantly, I have learned that a leader cannot thrive without ethics. According to Trevino, Hartman, and Brown (2000), ethical leaders make decisions that respect the integrity and dignity of others. Moreover, they insist on being fair, considerate, and honest. As a result, I learned that leadership entail not only motivating or inspiring people, but also being concerned about their welfare. The arguments on ethical leadership inspired me to revisit my decision-making skills. Furthermore, it made me understand why some leaders are successful while other are not. As a future leader, the ethical leadership theories challenged me always to consider the interests of others in every situation. In fact, it made me realize that leadership is about the welfare of the society not of the leader. However, I have to make several improvements to be an effective leader. Leadership calls for an individual to have excellent and effective communication skills. Without effective communication skills, a leader cannot motivate or inspire others. Despite having good communication skills, I struggle when it comes to public speaking. To enhance my public communication skills, I need to engage in group activities actively. Actions like group discussions provide an exceptional environment for individuals to develop appropriate interpersonal communication skills and courage. Additionally, I need to learn more on cross-cultural leadership. Currently, globalization has eliminated cultural barriers in leadership. People now talk about leadership in a global context. In a global environment, a leader interacts with individuals from diverse cultural backgrounds. Bertocci (2009) notes that the world is not static so is leadership. Leadership evolves with time. In the future, leaders will be required to possess exceptional multi-cultural leadership competencies. Consequently, I must expose myself to the various significant global cultural issues that impact on leadership. This goal requires me to interact with people from different cultures and studies on multicultural leadership. Leadership is practical. Reading loads of leadership materials will be in vain if the skills acquired are not exercised. In this respect, I will actively engage in leadership actions at different capacities. Taking leadership positions will enable me to experience the challenges that leaders endure in their daily activities. As Bertocci (2009) points out, leaders interact with people with differing interests. Moreover, these people hail from different backgrounds. Dealing with different people makes leadership a complex affair which requires experience. Apart from gaining leadership insights, participating in leadership roles will provide me sufficient feedback on my abilities and drawbacks. Obtaining frequent feedbacks will empower me to work objectively to improve my shortcomings. Additionally, I will consistently interact with various leaders to gain awareness on how they operate. I believe that the amalgamation of these interactions with what I have learned during this semester w ill assist me to improve my leadership abilities. With the course material confirming the leadership can be nurtured, I will work hard to attain the vital leadership competencies. Conclusion The semester materials have equipped me with sufficient insights on leadership and its vital elements. Throughout the term, my understanding of leadership has significantly improved. Particularly, I have been able to differentiate leadership from management. Moreover, I have understood the key competencies required for effective leadership. The various leadership theories covered in the semester have enriched my comprehension on the evolution of leadership and how it relates to the changes in the society. However, the course has also challenged me to improve by leadership aptitudes. Specifically, I need to improve my communication efficiency and insight on the leadership environment. To attain these goals, I will actively participate in leadership roles, network with various leaders, and read literature on leadership. In summary, the semester materials have significantly changed my perceptions on leadersh References Baumgartner, R. (2009). Organizational culture and leadership: Preconditions for the development of a sustainable corporation. Sustainable business Development, 17(2), 102-113. Bertocci, D. I. (2009). Leadership in Organizations: There is a Difference Between Leaders and Managers. New York: University Press of America. Burke, S., Collins, K. M. (2001). Gender differences in leadership styles and management skills. Women in Management Review, 16(5), 244-256. Day, D. (2000). Leadership development: A review in context. Leadership Quarterly, 11, 581-613. Fairhurst, G. T., Connaughton, S. L. (2014). A communicative perspective. accounting, 10(1), 7-35. Kotter, J. P. (2008). Force For Change: How Leadership Differs from Management. New York: The Free Press. Northouse, P. G. (2012). Leadership: Theory and Practice (6th ed.). London: SAGE Publications. Trevino, L. K., Hartman, L. P., Brown, M. (2000). Moral person and moral manager: how executives develop a reputation for ethical leadership. California Management Review, 42(4), 128-142.

Keiretsu and Chaebols Essay Example For Students

Keiretsu and Chaebols Essay Keiretsu and Chaebols Keiretsu a group of closely related Japanese companies, often with interlocking ownership. Traditionally, there have been both horizontal and vertical keiretsu. Horizontal keiretsu center on a main bank and their companies span various industries. Vertical keiretsu center on a major manufacturer, like Toyota, and include its various suppliers and wholesalers. The keiretsu encourage its members to award contracts to sister companies and cooperate with each other for the overall good of the keiretsu. The keiretsu dominated the Japanese economy in the last half of the twentieth century. More recently, however, the keiretsu have been losing their grip, and the long-term business relationships of the keiretsu are fraying. When written in Japanese, keiretsu comprises two characters, meaning system and row. Thus the term keiretsu is now used more generally to mean an alliance of companies and individuals that work together for mutual benefit Chaebols The chaebol are the large, conglomerate family-controlled firms of South Korea characterized by strong ties with government agencies. The name, which means business association, is properly pronounced jay BOL but the spelling pronunciation chay bol is considered acceptable by Korean speakers. There were family-owned enterprises in Korea in the period before 1961 but the particular state-corporate alliance came into being with the regime of Park Chung Hee (1961-1979). The chaebol were prohibited from owning a bank. The Park regime nationalized the banks of South Korea and could channel scarce capital to industries and firms it saw as necessary for achieving national objectives. The government-favored chaebol had special privileges and grew large. This gave the impression of economic success for the chaebol that was not always valid. In some cases chaebol grew not because they were profitable but merely because they could borrow vast funds. When the international economy took a downturn these debt-ridden businesses were in trouble. In 1999 one quarter of the manufacturers in South Korea did not earn enough to meet the payments required for their debt. In recent years there has been the growth of mid-sized corporations which are outside of the chaebol arrangement. For example, Appeal Telecom was started by a former employee of Samsung, Lee Ga Hyoung. Appeal Telecom is manufacturing and marketing cell phones and has risen to the top in its field. In Germany the mid-sized corporation make a great contribution to the economy and there is no reason that such firms could not be an important element of the South Korean economy. How can Toyota regain its position in the hearts and minds of consumers after the massive car recalls beginning of this year? Toyota Turns To Twitter To Repair Its Image Toyota has been dealing with negative backlash from the massive safety recalls of its vehicles; and is even suffering in terms of sales. The Japanese auto giant has launched a branded channel on TweetMeme, in partnership with Federated Media, which aggregates and organize Twitter conversations regarding Toyota. Called Toyota Conversations, the site brings together the top stories being Tweeted about Toyota, from news articles to press releases. The site also shows visitors the most popular videos and images being shared about Toyota on Twitter. And the channel includes a Featured Tweets from Toyota’s Twitter account and press room as well as AdTweets, which are Tweetmeme’s retweetable ads for Toyota Negative news no more? As most of the top stories that are being aggregated on the site, that most of them is positive and thus doesn’t match that of the negative news that seemed to match the general tone of the media writing about Toyota, which has been quick to criticize the car company for its manufacturing mistakes. .ue1c6762c3ec550bb15b7e98524e4d770 , .ue1c6762c3ec550bb15b7e98524e4d770 .postImageUrl , .ue1c6762c3ec550bb15b7e98524e4d770 .centered-text-area { min-height: 80px; position: relative; } .ue1c6762c3ec550bb15b7e98524e4d770 , .ue1c6762c3ec550bb15b7e98524e4d770:hover , .ue1c6762c3ec550bb15b7e98524e4d770:visited , .ue1c6762c3ec550bb15b7e98524e4d770:active { border:0!important; } .ue1c6762c3ec550bb15b7e98524e4d770 .clearfix:after { content: ""; display: table; clear: both; } .ue1c6762c3ec550bb15b7e98524e4d770 { display: block; transition: background-color 250ms; webkit-transition: background-color 250ms; width: 100%; opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; background-color: #95A5A6; } .ue1c6762c3ec550bb15b7e98524e4d770:active , .ue1c6762c3ec550bb15b7e98524e4d770:hover { opacity: 1; transition: opacity 250ms; webkit-transition: opacity 250ms; background-color: #2C3E50; } .ue1c6762c3ec550bb15b7e98524e4d770 .centered-text-area { width: 100%; position: relative ; } .ue1c6762c3ec550bb15b7e98524e4d770 .ctaText { border-bottom: 0 solid #fff; color: #2980B9; font-size: 16px; font-weight: bold; margin: 0; padding: 0; text-decoration: underline; } .ue1c6762c3ec550bb15b7e98524e4d770 .postTitle { color: #FFFFFF; font-size: 16px; font-weight: 600; margin: 0; padding: 0; width: 100%; } .ue1c6762c3ec550bb15b7e98524e4d770 .ctaButton { background-color: #7F8C8D!important; color: #2980B9; border: none; border-radius: 3px; box-shadow: none; font-size: 14px; font-weight: bold; line-height: 26px; moz-border-radius: 3px; text-align: center; text-decoration: none; text-shadow: none; width: 80px; min-height: 80px; background: url(https://artscolumbia.org/wp-content/plugins/intelly-related-posts/assets/images/simple-arrow.png)no-repeat; position: absolute; right: 0; top: 0; } .ue1c6762c3ec550bb15b7e98524e4d770:hover .ctaButton { background-color: #34495E!important; } .ue1c6762c3ec550bb15b7e98524e4d770 .centered-text { display: table; height: 80px; padding-left : 18px; top: 0; } .ue1c6762c3ec550bb15b7e98524e4d770 .ue1c6762c3ec550bb15b7e98524e4d770-content { display: table-cell; margin: 0; padding: 0; padding-right: 108px; position: relative; vertical-align: middle; width: 100%; } .ue1c6762c3ec550bb15b7e98524e4d770:after { content: ""; display: block; clear: both; } READ: Dress Code EssayWith Tweetfeel ( Twitter sentiment application), it seem that Toyota has chosen this as it can be step up to pick only certain news sources which may be positive to them. And by looking at how Twitter has influence things between numerous brands, Toyota has chose to follow suit and this allow Toyota not only to monitor and track what is begin said about Toyota but to influence and participate in the conversation. The main ideas behind Toyota utilizing Twitter are: 1) To help stem the tide of negativity and 2) To deal with the backlashes that have been heaped upon it during the car recalls period. Toyota’s twitter site does mainly revolves around assimilating the top stories being Tweeted about Toyota, such as news articles and press releases, while showing visitors the most popular videos and images being shared about Toyota on Twitter. Akios Plan Akio Toyoda is the president and CEO of Toyota Motor Corporation Lately, Toyota has not lived up to the high standards we set for ourselves. I am deeply disappointed by that and apologize. That is why I am personally leading the effort to restore trust in our word and in our products. 1. Launch a top-to-bottom review of our global operations to ensure that problems of this magnitude do not happen again and not only meet but also exceed high safety standards. 2. Ensure that our quality-control operations are in line with best industry practices. 3. Aggressively investigate complaints we hear directly from consumers and move more quickly to address any safety issues we identify. You have my commitment that Toyota will revitalize the simple but powerful principle that has guided us for 50 years: Toyota will build the highest-quality, safest and most reliable automobiles in the world.