Food technology portfolio sac paper Essay

To demonstrate satisfactory completion of Unit 3, Outcome 3, you must present evidence of the development of a design brief, evaluation criteria and a design plan. This document is a framework for the development of the SAT. It provides a step-by-step approach to completing all of the components of the task so that you are able to complete all of the assessment criteria to the highest level. The task is more manageable if you type all your documents as you go. This will save a lot of time and make it easier to incorporate corrections from your draft. When setting up a new folder for your SAT on your computer, separate folders for individual components of the task. However, it is recommended that the research and the production notes for each individual food item are prepared in the one document. This will enable you to ensure that the footnoting in this document is sequential. REMEMBER TO SAVE YOUR WORK IN MORE THAN ONE PLACE AND TO BACK-UP YOUR WORK EACH TIME YOU WORK ON THE TASK. As you undertake research, remember to record all sources of information you have used and footnote any material that is directly cited or copied. Start you bibliography as soon as you begin your work on the SAT. More information about citing reference and writing your bibliography will appear later in the booklet. It is always helpful to proof read your draft to pick up mistakes 4 Unit 3 / 4 Food and Technology SAT 2012 Criteria for Assessment Unit 3: Food preparation, processing and food controls Area of study 3: Developing a design plan Outcome 3: Develop a design brief, evaluation criteria and a design plan for the development of a food product. Unit 4: Food product development and emerging tends Area of study 1: Implementing a design plan Outcome 1: Safely and hygienically implement the production plans for a set of four to six food items that comprise the product, evaluate the sensory properties of the food items, evaluate the product using the evaluation criteria, and evaluate the efficiency and effectiveness of production activities. Criteria 1: Design Brief and Evaluation Criteria Criteria 3. Skill in developing a design brief and evaluation criteria ? Skill in developing a design brief including context and specifications (considerations and constraints) ? Skill in developing relevant evaluation criteria that relate to the design brief context and specifications. Very High Comprehensive, coherent and relevant information is provided in a very well structured design brief with a clear and thorough description of the context. The specifications in the design brief (considerations and constrains) are very clearly identified. A range of very clearly expressed, relevant evaluation criteria reflect all the information contained in the design brief context and specifications. 5 Design Brief: ? clearly defines the context, aims and intentions of a new product? includes specifications – considerations and constraints – that need to be taken into account when making decisions in relation to the design of the new product ? Must be a problem that the student will attempt to solve ? must be developed and written by the student (not by the teacher) ? must allow students to demonstrate key knowledge and skills. There is no word limit on the length of the design brief. The VCAA has a PowerPoint presentation ‘In the beginning – Developing an effective School-assessed Task design brief’ available at www.vcaa. vic. edu. au/vce/studies/foodtech/foodtechindex. html Example: www. vcaa. vic. edu. au/vce/studies/foodtech/foodtechindex. html Of all the sports I have ever played, surfing is without doubt my favourite. I really can’t remember a time when I haven’t been able to surf. My Nan and Pa have had a house at Torquay since I was just a toddler and so we have spent most weekends there every summer. My Pa was one of the original ‘surfies’ at Jan Juc and other beaches along the surf coast and he taught me to surf when I was really young. Two of my friends from school, Ben and Sam, are also keen surfers and so we have decided to head to the surf for a couple of days after our final exams in early December for our own ‘Shortboard Classic’. My Nan and Pa have offered to let us stay at their house on Friday and Saturday but we will need to take some of our own ‘supplies’ as I don’t want Nan to have to do all of the meal preparation. As I quite enjoy cooking, I have decided to make some of the main food items we will eat over the two days. We will need some food items for a casual dinner on Friday and breakfast and lunch on Saturday. I will also need to prepare some savoury and sweet snack items we can take to the beach, as we will no doubt be hungry after spending so long in the water. On Saturday night we will have a celebratory dinner with my Nan and Pa before we leave and so I will need to make a dessert to share for dinner. The dessert needs to be quite special and look spectacular so that it is the ‘grand finale’ to a great weekend. Just as importantly, I can show my Nan that all the hours she spent teaching me how to cook while we were staying at Torquay weren’t wasted! The food will also need to be appealing to us and satisfy our ‘healthy’ appetites. As we will be leaving for Torquay straight after our last exam, all of the food needs to be prepared several weeks in advance and have good keeping qualities. I also want to use a variety of complex processes so that the products I produce are of a very high quality. My Nan is a great fan of television cooking shows and I want to show her that I am now quite a skilled cook too – even if not yet in the league of the experts on her favourite show! 6. IDENTIFY a theme, event or context. WHO: Who has asked you to prepare the product? This might be an individual or a representative of an organisation. Remember to outline or describe some background information about who the product is being prepared for to inform the reader. WHY: Why is the product needed? Discuss the reason or purpose the product needs to be prepared. 7 WHAT: What needs to be prepared? This should be a simple outline or general statement about the product. WHEN: When the product is to be prepared by or served or available. WHERE: Where the product is to be served, displayed or used. 8 Developing your brief Once you have established your ideas, use the 5 W’s chart to write your detailed design brief. Remember to use complete sentences and paragraph format. These five components will form one or two paragraphs of the design brief. Scope of the task – this information must also be included as a part of your design brief: – A range of 4-6 food items – Use at least 4 different complex processes in the production work to produces high quality food 9 Specifications & Criteria for Evaluation You now need to use the information in your design brief to develop the criteria for evaluation. The first step is to identify the specifications (constraints and considerations) in your design brief. 1. On your design brief underline or highlight the specifications. Alternately you could make a list of the specifications. It is important that these are clearly identified. Specifications are the issues or barriers that have been identified in the brief. They will need to be addressed when working through the design process. ‘Considerations’ are flexible restrictions – issues or aspects that need to be taken into account when planning a product. ‘Constraints’ are restrictions, over which the designer has little control, that affect the development of the product. 2. Using the specifications identified, develop approximately 5 to 6 relevant evaluation criteria questions. If you have a lot of specification you might want to combine more that one specification into a question. a. Must be relevant/related to your design brief. b. Must be written before the product or the food items are made c. Should be a set of open-ended questions that need more than yes or no as an answer d. Need to be well-written and clearly expressed 3. These questions will be used to evaluate the set of food items as a single product rather than individual items once you have completed your production work. Students should write clear and in depth responses to evaluation questions. These responses form part of the evaluation component of the task after all the food items have been made. 10 Example: www. vcaa. vic. edu. au/vce/studies/foodtech/foodtechindex. html Of all the sports I have ever played, surfing is without doubt my favourite. I really can’t remember a time when I haven’t been able to surf. My Nan and Pa have had a house at Torquay since I was just a toddler and so we have spent most weekends there every summer. My Pa was one of the original ‘surfies’ at Jan Juc and other beaches along the surf coast and he taught me to surf when I was really young. Two of my friends from school, Ben and Sam, are also keen surfers and so we have decided to head to the surf for a couple of days after our final exams in early December for our own ‘Shortboard Classic’. My Nan and Pa have offered to let us stay at their house on Friday and Saturday but we will need to take some of our own ‘supplies’ as I don’t want Nan to have to do all of the meal preparation. As I quite enjoy cooking, I have decided to make some of the main food items we will eat over the two days. We will need some food items for a casual dinner on Friday and breakfast and lunch on Saturday. I will also need to prepare some savoury and sweet snack items we can take to the beach, as we will no doubt be hungry after spending so long in the water. On Saturday night we will have a celebratory dinner with my Nan and Pa before we leave and so I will need to make a dessert to share for dinner. The dessert needs to be quite special and look spectacular so that it is the ‘grand finale’ to a great weekend. Just as importantly, I can show my Nan that all the hours she spent teaching me how to cook while we were staying at Torquay weren’t wasted! The food will also need to be appealing to us and satisfy our ‘healthy’ appetites. As we will be leaving for Torquay straight after our last exam, all of the food needs to be prepared several weeks in advance and have good keeping qualities. I also want to use a variety of complex processes so that the products I produce are of a very high quality. My Nan is a great fan of television cooking shows and I want to show her that I am now quite a skilled cook too – even if not yet in the league of the experts on her favourite show! Research. Criteria for Evaluation – 1. Have I been able to prepare a range of food items suitable for a casual dinner on Friday and breakfast and lunch on Saturday? 2. Was I able to produce some savoury and sweet snack items suitable to take to the beach? 3. Did the range of food items include a special dessert to share for dinner on Saturday night? 4. Will the food be appealing to young males and will it be filling enough to satisfy ‘healthy’ appetites? 5. Was all of the food able to be prepared several weeks in advance and did it have good keeping qualities? 6. Did I use a variety of complex processes in the preparation of the products to produce high quality products? Constraint: food items for dinner on Friday, and breakfast and lunch on Saturday Consideration: types of food for brecky, lunch and dinner Constraint: sweet snacks to take on the beach Consideration: the type of sweet snacks Constraint: dessert to share at dinner that looks spectacular Consideration: the type of dessert Constraint: food needs to look appealing and satisfy ‘healthy’ appetites Constraint: food will need to be prepared several weeks in advance and have good keeping qualities Constraint: products of high quality Consideration: use a variety of complex processes 11 Criteria 2: Design Plan Criteria 3. Skill in completing research relevant to the design brief, developing ideas, and documenting decisions. ? Skill in completing a range of research relevant to the specifications in the design brief. ? Skill in exploring ideas for possible food items in response to the design brief. ? Skill in selection and justification of the decision made for the set of four to six food items (the product) Very High Comprehensive range of relevant research related to the specification in the design brief. Very detailed exploration and creative formulation of a wide range of ideas in the selection of the set of food items (The product). Highly detailed documentation of thought processes and thorough justification of decision making related to the suitability of selected food items, and detailed reasons why some have be en rejected. 12 Research and exploration – After writing your design brief you will need to ask yourself the following question: What information do you need to know about your theme or idea to help guide your food ideas and final selection? You will need to explore a range of ideas or alternatives in order to make informed decisions about what food items you would like to produce to solve the problem outlined in your design brief. There needs to be creativity in the selection of food items and decisions made in order to solve the problem set out in the brief. This information must be directly related to the specifications in the design brief and should be no more than approximately one to two A3 pages. You will need to use a range of primary and secondary sources. When exploring ideas in order to make decisions students should make use of: – Existing solutions e. g. recipe books Guiding information from people, internet recipes, books, magazines, television etc Primary and secondary sources of information o Primary sources include: ? Visiting a supermarket or fresh food market to observe particular varieties of produce ? Interviewing a grower at a farmer’s market ? Interviewing a person with expert food knowledge ? A visit to a restaurant to sample new foods o Secondary sources include: ? Books ? Magazines? Websites ? Journal articles It is very important that students acknowledge all sources of information using a recognized reference system with footnotes and a bibliography. 13 Example brainstorming ideas You must footnote all of the resources you have used to gather this information. Remember to write the information from your secondary research in your own words and do not include downloads or screen dumps from websites. Prepare a diagram to outline useful information about components or characteristics of the food items that will guide your recipe search and meet the needs of the design brief. You should include 4-5 ideas for each food item. This is not a recipe search but a way of documenting some of your thought processes after you have started your research. This may be a simple, hand-drawn map mind map to capture your initial thought or it can be produced using a software package such as Inspiration or Mindmanager. 14 Selection of recipe ideas Now you must research possible recipe ideas based on the information in your mind map. You will need to have at least three (3) possible ideas for each food item that must also meet the specifications in the design brief. Your selection of the food items MUST be creative and of a Year 12 standard. You will need to make decisions about which products will be most appropriate. It will be helpful to consider the following points before you make your final decision: – You need to prepare a minimum of four and a maximum of six items – Make sure you have the food preparation skills required to prepare each food item to a high quality. – Be creative with the selection of food items – consider interesting combinations of ingredients, as well as the presentation of each item. – Try to be objective in selecting products and don’t just choose food items because they are ones you are familiar with or are special favourites – Make sure that some food preservation techniques are included in the selection of products. – You must also use a range of complex processes in the production processes as well as a variety of cooking techniques. Food solutions 3 & 4 – Third Edition 2010, pg172. Reference Complex Process Cooking Technique / Preservation Comments about how the product will creatively meet the needs of the design brief. Food Item 1: Recipe Name: Recipe Name: 15 – Design Ideas – Recipe Ideas Reference Complex Process Cooking Technique / Preservation Comments about how the product will creatively meet the needs of the design brief. Food Item 1: Recipe Name: Recipe Name: Recipe Name: 16 Reference Complex Process Cooking Technique / Preservation Comments about how the product will creatively meet the needs of the design brief. Food Item 2: Recipe Name: Recipe Name: Recipe Name: 17 Reference Complex Process Cooking Technique / Preservation Comments about how the product will creatively meet the needs of the design brief. Food Item 3: Recipe Name: Recipe Name: Recipe Name: 18 Reference Complex Process Cooking Technique / Preservation Comments about how the product will creatively meet the needs of the design brief. Food Item 4: Recipe Name: Recipe Name: Recipe Name: 19 Reference Complex Process Cooking Technique / Preservation Comments about how the product will creatively meet the needs of the design brief. Food Item 5: Recipe Name: Recipe Name: Recipe Name: 20 The following will record your final selection of food items that will make up your product for production. Hint: use your criteria for evaluation as a way of making decisions about which food items to select as part of your final product. Food Item Specification Complex Process Cooking Method Preservation Technique Item 1: Item 2: Item 3: Item 4: Item 5: Item 6: 21 Justification of selected food items – You must justify each of the food items you have selected individually. – The justification for each food item should be approximately 100 to 150 words in length. – Your discussion should outline how the item meets the specifications in the design brief and may include some or all of the following: o identification of the product o how the product relates to the theme o how the product will meet the other specifications/needs of the brief o identification of any complex process that will be used to prepare the food item o identification and description of cooking methods o if applicable, discussion of the preservation techniques to be used for this item o a discussion of the creativity of the food item o an explanation of why each of the other two recipe ideas were not selected. 22 Criteria 6: Overall production timeline, individual food item production plans and production work Criteria 6. Skill in development, organization and implementation of planning for production. ? Skill in developing an overall production timeline. ? Skill in developing individual production plans for each food items to be made. ? Skill in organisation and implementation of the overall production timeline and individual food item production plans to complete the food items. Very High Completing of a cohesive, carefully considered sequence and clearly presented overall production timeline. Development of a very detailed individual production plans for each food items to be made. A very high level of organisation demonstrated throughout the completion of the food items. * Food orders, production plans all submitted by due dated. * Need to include presentation in any planning documentation. 23 Overall Production Plan The next step in the development of your design plan is to prepare an overall production timeline showing how you will prepare all of the 4 to 6 items you selected in the time you have available. This will help you to organize the sequence in which you will produce each of the chosen food items. It should take into account the length of time each food item takes to prepare along with other commitments Individual work plans will be prepared later. The type of information you will need to include on your overall production timeline is: – The date each food item will be produced – Any preparation which needs to be done prior to preparing the food item such as soaking dried fruit for jam, marinating of meat, selecting jars for preserved products, collecting props for photography. -Note any other important school or personal commitments you will have during this period which will have an impact on you over this time. – 24 March 2013 SUN MON TUES WED THUR FRI 31 SAT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Notes: 25 April 2013 SUN MON TUES WED THUR FRI SAT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 15 Notes:Â  May 2013 SUN MON TUES WED THUR FRI SAT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 15 Notes: 27 June 2013 SUN MON.

Consumer Securities Trading in United States

The following is an in depth look at the effects the Internet has had on trading securities in the United States. Its purpose is to define the impact of the Internet by determining specific changes in the structure of the trading market as a result of the numerous online brokerages that have surfaced in the past few years. A brief look at traditional brokerages and market characteristics prior to the advent of the Internet provides a foundation with which to measure many of its impacts. The arrival of the online brokerage model has not only introduced an entirely new vehicle with which to trade securities, but it also beginning to effect the way traditional brokerages view their own business models. Specifically, it appears that both the online/discount model and full service model of brokerages will both succeed in the next few years, with the top firms exhibiting characteristics somewhere between the two extremes. New Ameritrade television commercials debuted early this year with a twenty-something-year-old punk extolling the virtues of his new brokerage account to various business men and women. Perhaps the witty E*trade commercial featuring monkeys that first aired during the 2000 Super Bowl was more notable. These commercials are quite a contrast to the traditional brokerage commercials of Merrill Lynch, Morgan Stanley Dean Witter, and Fidelity among others. This contrast is for good reason. Online brokerages have uprooted the traditional model of consumer securities trading and have attracted a critical mass of followers. Before brokerage fees were deregulated 1975, eliminating fixed commissions, trading was something only done by the wealthy. Since then, fees have dropped considerably among the full-service firms making it possible for more and more people to manage portfolios. Until 1995 there was still a fundamental restraint for many consumers: access to timely and accurate information at any time from their own computer. With the arrival of online brokerages in 1995 came a slew of options for investors, new and old, to access an abundance of information and research, and to initiate their own trades all at considerably discounted fees. According to Deutsche Banc, as of 2Q00, online brokerage accounts represented approximately 25% of all accounts in the United States. Furthermore, by 2003, online brokerage accounts are estimated to control 50% of the brokerage market. The online model has already attracted nearly 20 million investors, initiating an increase in overall trading volume. An brief examination of the brokerage industry pre-arrival of the Internet and an in depth look at the brokerage industry now illuminates the many differences and possible implications for the future of consumer securities trading in the United States. Traditional brokerages have been operating freely since 1975. The deregulation of brokerage fees at this time allowed new firms to enter the market, marking the first major alteration in the way Wall Street traditionally offered its services. Before 1975, the market consisted solely of â€Å"full service† firms, those firms who offer trading, research, and financial advice through brokers or financial advisors at a considerable fee. After fees were deregulated, â€Å"discount† firms began to appear, offering consumers smaller fees, but at the cost of less research and financial advice. The market slowly split between these two types of business models, but they were fundamentally similar for 20 years: generate revenue by providing consumers the ability to trade and receive financial advice based upon firm research. The concept of having a broker, or financial advisor who acts as an agent for consumers, was the prevailing idea of stock trading in between 1975 and 1995. Many of those who had portfolios would leave its management entirely up to their brokers, others would call periodically for advice, and some would be actively co-managing their portfolios with the broker. The prevailing model for securities trading was still professionally managed, although different levels of management and cost evolved at this time. Wall Street was altered again in 1995, probably more significantly than in 1975, when securities trading and the Internet converged. According to the Securities Industry Association, K. Aufhasuer & Company was the first to execute securities trading online in 1994. However, it was not until 1995 that the first online brokerages debuted their new business model. Momentum mounted quickly, as many investors flocked to the lure of extremely discounted prices and quick trade execution. Without the â€Å"brick and mortar† presence typical of the traditional brokerages and a significantly less extensive network of research and financial advice, online brokerages can offer transactions at fractions of the costs of traditional brokerages, even of the traditional discounters. The first online investors were, and still are, predominantly â€Å"a mix of young, first-time investors and older, more experience ones,† according to a McKinsey & Company study. When online brokerages first surfaced, they introduced an entirely unique channel for delivering securities trading to consumers. No other brokerage firms offered the ability to trade securities over the Internet; it was exclusively reserved for those companies referred to as â€Å"online brokerages. † This has changed however over the past couple of years. Traditional full-service brokerages are beginning to adopt their own online components. The two most frequently cited reasons for the scramble of full service firms to enter the online market were customer pressure, and the fear of asset flight to online brokerages, according to a Deloitte & Touche Survey. The ability to distinguish these early online brokerages from full service firms is no longer a matter of whether or not they offer online services. The distinguishing feature now is between the cost of their services, segregating firms into a classification again of â€Å"discount† or â€Å"full service. In a sense, the online model has redefined â€Å"discount,† moving the discount brokerage to a much further extreme. Indeed, it is true that most of the firms that are classified today simply as â€Å"discount† are founded on an online business model or have quickly adopted online capabilities, but many of the full service firms, as mentioned, are turning to the online channel in hopes of competing with the discounters. Therefore, when an â€Å"online brokerage† is referred to, it implies both the discount firms and the few full service firms with online capabilities. The evolution of the online brokerage market has been explosive in growth, catapulting from just one online brokerage in 1995 to an estimated 170 in 2000, totaling 19. 5 million online accounts (refer to Figure 1 below). The first online brokerages to emerge were predominantly â€Å"deep† discount, followed by mid discount firms, and finally some of the traditional discount incumbents adopted an online strategy and are now classified as mid-tier firms. To illustrate this trend, consider the emergence of 5 of today's top 6 online brokerages: In 1996, two major deep discount firms emerged, Datek and Ameritrade. Over the next two years, two major mid-discount firms appeared, E*trade and DLJdirect. In 1998, Charles Schwab made their presence felt in the online market which was one of the few traditional discount firms before the online model developed. Fidelity quickly followed suit. This upsurge of online brokerages and the trend for some of the traditional brokerages to go online has had some lasting effects on the securities trading market, which will be explored in the next two sections. The impact of online brokerages is manifested in nearly every aspect of the securities trading market today. Trading volume increase is one of the largest impacts, as a result of the ease and availability of trading that online accounts bring to consumers. It is worth examining the numbers to determine if the large increases in trading volume are actually a result of online accounts, or merely pure correlation with a booming bull market. Over the past decade, the volume of shares traded on the NASDAQ stock market has grown at a compound annual rate of 26%, but since the arrival of online brokerages in 1995, it has grown at a rate of 30%. Although this is not an enormous increase, it is certainly quite significant. To look at it in another light, online accounts represented 15% of all brokerage accounts in the US, but more than 37% of the trading volume. Based upon past experience in the stock market, it may seem that this increase in trading volume is an entirely productive result. However, much of the trading volume from online accounts is a result of day trading, which raises concerns with the SEC. Day trading was not possible before online brokerages made it possible to quickly and effectively trade securities multiple times daily. It is a speculative business, more so than the traditional brokerage business. As Deloitte & Touche describes it, â€Å"Customers usually [trade] in and out of several securities positions every day hoping to earn a positive spread on their transactions. † The SEC is responsible for maintaining fair and orderly markets, to protect investors, and to enforce securities laws that were established upon principles that day trading discards. According to a Deloitte & Touche survey, 62% of discount firms said they would offer services to day traders versus 0% at full service firms. Most online brokerages recognize that day traders make up an integral portion of their customer base, and do not wish to sacrifice the relationship. Day trading is one negative result of the advent of online brokerages that will remain a challenge for some time to come. Another notable consequence of online brokerages is the further development of after hours trading. The New York Stock Exchange first expanded its hours to â€Å"off hours† trading in 1991. The NYSE added a modest extension extending the after hours from 4pm to 5:15pm. It is now possible, with an online account to trade at any time. This can be advantageous to many investors in giving them more flexibility regarding time availability and for investors overseas who have holdings in US securities and cannot trade at regularly scheduled hours. After hours trading in 1999 represented 50% of all online transactions. Online brokerages have improved execution time quite dramatically to an average of 20 seconds per trade versus nearly 60 seconds for full service firms. In addition to improved execution time, the reliability and accuracy of online executions at discount firms is generally considered to be far superior to full service firms' online counterparts. The reasons most frequently cited for this are two-fold. First, most discount firms are built upon an online model, it is their core competency, allowing them to devote all of their efforts to perfect the core of their business model. Discount firms rely on trade volume for revenue, not asset accumulation, so it is imperative that their trade execution is the best that it can be. The second reason for superior trade execution at discount firms is that full service firms simply do not devote the same technological resources to their online channel. Full service firms focus primarily on performing cutting edge research, and providing sound financial advice through its network of brokers. The speed and reliability in execution at discount firms has been one of the top attractions of investors, along with largely discounted prices. The online brokerage market has also greatly impacted the availability of brokerage services to those who were previously unreachable. This hinges upon Internet penetration in the US, which is approaching 120 million active adult Internet users, or a penetration rate of 50%. As was mentioned previously, the first investors to move online were mainly those who were brand new to securities trading, or those who were experienced enough to feel confident trading with little or no professional advice. Most of them brought below average asset values online. In fact, in mid-1999, although online accounts represented 15% of all brokerage accounts, they only represented 5% of the total assets. As stated previously, these accounts also accounted 37% of the trading volume. That would indicate that the online brokerages do not focus on producing revenue through asset accumulation, but through trading volume. This has some major implications to be discussed in the next session. The majority of discount firms rely on trading volume to create revenue through their online offerings. This means they depend on accumulating customers who trade frequently in order to collect fees for trades made. Trade volume has been increasing quite dramatically over the past few, as the percentage of online trades increases as a proportion of total. This bodes well for the online brokerages who are accumulating customers, although those players who are at the bottom of the pack will likely fall out soon. The market is remarkably consolidated after just 4 years in existence. In fact, the top ten online brokerages comprise 90% of the online assets and accounts, and the top 4 comprise 86%. Those brokerages who are having a tough time accumulating customers and trade volume even while the online brokerage market is hot, will likely fall out soon. Referring back to Figure 1, it can be seen that the number of online brokerage firms is expected to decrease over the next few years while the number of online accounts increases. The online industry is consolidating quickly while continuing to grow. Although there is still a large disparity between discount firms and full service firms in terms of how they operate and what they offer, this is likely to change in the coming years. Already, the trend for full service firms to go online is in motion, and there are even some discount firms that are beginning to complement their trading services with plans for banking, insurance, and bill payment services. Currently, discount firms have approximately 74% of their transactions online versus 18% online at full service firms. In a Deloitte & Touche survey, 100% of full service firms said they planned to use online trading to enter new businesses, create alliances, or shift the business model, and 74% of discount firms said they planned to add additional services that are typically offered only by full service firms. It appears that the two extremes in brokerage services are headed towards a common middle ground. As the author of the Deloitte & Touche study put it, â€Å"the distinction between discount brokers and full service firms is becoming less evident. There is distinct evidence that the brokerages that will prevail in the next decade will have features of both a discount brokerage and a full service brokerage. A 50/50 hybrid model of online and full service could prevail, but it is more likely that the future constituents will be based on one core competency (online vs. full service) and have significant characteristics of its counterpart. This is because each business model appeals to different segments of the population. It is generally agreed that full service firms have a distinct advantage in advertising dollars and brand equity, and appeal to investors with more money and/or less knowledge of investing. Online brokerages appeal generally to investors with less money and/or more knowledge of investing. At this point in time, they are quite distinct, but the gap is closing. Another salient example of this phenomenon is that the top focus of current marketing strategies for 18% of online brokerages is to build brand equity, a la the full service firms. Each model, discount and full service, is moving to a common ground. The question that now stands is, who will win out? It is not an easy task to predict the future, or the future of brokerage services in the United States for that matter. One thing is for sure: the online channel will succeed. The top brokerages of the future will certainly incorporate online components very significantly. Those that will continue to succeed will be able to be flexible and adjust to the changing demands of consumers and technology, just as the top firms today are able to embrace the online channel. As Deloitte & Touche put it, â€Å"firms that cannot be innovative will find themselves niche players or acquisition targets. â€Å"

Mental Health Counseling

Professional competence among practicing mental health counselors has not been resolved yet whether it is attained through a licensure or higher educational training of this field.   As per many researches that have been conducted, it takes a lot of training and experience before one could get competence.   Besides, counseling a person with a mental health problem requires adequacy and expertise because irrelevant referral may result to a more aggravated condition on the part of the patient.   Thus, the issue of competence among mental health counselor requires a more rigid consideration for comprehensive trainings designed to develop competency. Professional competency is not acquired easily after four years of education in college nor if someone practicing it finds counseling a less difficult one.   Even highly experienced therapist may also seek professional help or doubt their abilities as counselors according to Gerald Corey, Marianne Schneider Corey and Patrick Callanan (p. 315).   This is why; many experts recommend a kind of training for these counselors in order to meet criteria of a competent counselor especially in dealing with mental health problem. There are practical ways in approaching difficult cases that requires good judgment.   In the first place, a counselor must identify whether he can do something about the problem, and refer that client to another therapist long before the allotted sessions end and not at the last day of therapy.   This only annoys the client and causes him to be disappointed further because of irresponsible referral. Based on the common issues observed in counseling sessions, the therapist must understand two factors that may contribute to his effectiveness: his judgment of the case and adequate training. Personal judgment of the case involves how a counselor evaluates the case and his own capability to handle it.   This also engages whether the case needs referral and when or how to communicate that to the client.   Referral is the last option when all the possible resources have been used up or exhausted. Training on other hand, is one basic component of competence.   Training must be comprehensive and organized in terms of selection of trainees, content, and best approaches to ensure desired results (Corey, Corey & Callanan, p. 319).   Meanwhile, the kind of training to obtain licensure is under the jurisdiction of the accreditation committee; however, in most cases, licensure is given to those who obtained degree of psychology in college.   Here, the necessary trainings to develop a student are incorporated in the curriculum.   Generally, hands-on training is the transition point of students to have him acquire knowledge and skills. The content of a training program should be structured around a specific theoretical orientation that revolves around challenges as seen by concerned groups such as schools and practicing practitioners. Corey, et.al. pointed out that content must be objective and practical enough to offer students a variety of therapeutic techniques and strategies that can be applied to variety of problems (p. 332).   Training program then must provide theoretical explanation to given problems in order to help them formulate rationale for every situation. Professional licensing may indicate that a person is competent as long as a comprehensive program is offered to students by the school and licensing department of the government.   – stated, â€Å"Licensing examination generally contains a written component which may be supplemented by oral examination or practicum exam (patient diagnosis or counseling).   These examination are commonly written or administered by the state board which also provides for scoring them and determines what â€Å"passing† scores are (p. 132). Also, on the part of the school, â€Å"The supervision work experience or practicum is meant to ensure that during the initial years of practice, the professional has the guidance necessary to deal with the complexities of practice.   It is a transition period between the intense supervision that is supposed to be part of academic training (p. 132). Work Cited Corey, G., Corey, M., & Callanan, P. Issues and Ethics in the Helping Professions 7th Edition. Smith, S. & Meyer, R. 1987.   Law, Behavior, and Mental Health: Policy and Practice. USA: NYU Press.      

Tesla in Dubai Essay Example | Topics and Well Written Essays - 500 words

Tesla in Dubai - Essay Example The company built a strong brand image that captures the attention of customers through celebrity impact. The company develops sleek car models that meet the expectations of the customers. The marketing strategy through social and traditional media has catapulted the company into celebrity limelight. The company’s customer –centric approach has also been one of the main factors for its success in Dubai. Tesla fosters a strong customer relationship, thus creating a positive image among consumers. The first strategy available for Tesla’s international expansion is strategic alliance. Tesla has the option of identifying other companies in foreign markets that have good performance history and join forces with them. The company can easily gain entry into foreign markets through mergers and acquisitions. Through mergers, Tesla will create joint ventures with potential competitors in the market while acquisitions will involve buy out of rival companies in the market. Mergers and acquisitions in foreign markets will enlarge the company’s customer base and also enhance intellectual capital as well as performance efficiencies of the resultant company (Benjamin, 2006). The second strategy that Tesla can use to expand into international markets is licensing. This strategy involves entering foreign markets through leasing a company’s intellectual property rights to a foreign firm (Kozami, 2005). Tesla can lease its technology, patents, brand name and trademark to companies in foreign markets. In this strategy, Tesla would be the licensor while the other companies to which it leases its intellectual property rights would be the licensee. Ireland, Hoskisson and Hitt (2008) argue that â€Å"licensing is popular because it involves little direct cost or risk for the licensor (p.158). Despite the fact that this strategy offers a cheap foreign

Discussion Board 2-1 Essay Example | Topics and Well Written Essays - 250 words - 2

Discussion Board 2-1 - Essay Example Ethically, researches involving human beings as samples must obtain informed consent of the participants to be subject to tests and measures (Bordens & Abbott, 2014). Researchers must only proceed with studies after obtaining the consent. To deal with the dilemma relating to difficulty of obtaining informed consent, a researcher can contact and persuade close relatives such as parents or guardians of the subject to give and sign consent. Another ethical dilemma that researchers may face when working with clinical population is the aspect of deception. According to Bordens and Abbott (2014), deception refers to giving false information to the participants in a research. Deception may also entail withholding of critical information from the participants so that they may make competent decisions. Some clinical research may force researchers to withhold certain information to perform research in a manner that addresses predefined goals. To tackle the issues of deception, a researcher should eliminate questions or elements that are controversial and likely to necessitate withholding of information or lying to achieve the desired

Case report need to add theory relvent to the discussion Essay

Case report need to add theory relvent to the discussion - Essay Example The next section deals with the analysis of the case. The analysis begins by listing down the organizational structure being followed by the organization before 1995 when restructuring took place. This is followed by the shortcomings of this organizational structure. The changes which were done by the organization as result of these shortcomings in the organizational structure are discussed next in the case. The benefits which were obtained by the firm as a result of these changes are also discussed. The last section of the report deals with recommendations to the Shell group in order to make the process of restructuring much more efficient. The paper concluded with the conclusion section which provides us with all major learning’s that have been obtained from the case. Royal Dutch Shell PLC is a multinational joint venture corporation comprising two founding companies, Royal Dutch Petroleum Co. of The Hague, Netherlands. And Shell Transport and Trading Co., PLC, of London. Although starting as rivals, the two companies merged in 1907 as Royal Dutch/Shell Group, which acquired producing concerns in the Middle East, the Americas, and Eastern Europe, including Romania and Russia. It is engaged mainly in oil and natural gas. At present its five business segments are as follows: 1) exploration and production (E&P), an upstream activity that explores, recovers, and produces oil and natural gas worldwide; 2) gas and power, where it liquefies and transports natural gas to customers, as well as turns natural gas into cleaner-burning synthetic fuels; 3) oil sands, where bitumen is extracted and converted into synthetic crude oils; 4) oil products where a range of petroleum-based products are sold for domestic, transportation and industrial use; and 5) chemi cals, which produces petrochemicals for industrial use. The case deals with the organizational changes that the company had to go through.

Church and State Assignment Example | Topics and Well Written Essays - 250 words

Church and State - Assignment Example The wordings used by Jefferson in framing the declaration of independence exposes the image of someone who although was aware of the dictates of religion and God, was reluctant to embrace it (Hamburger 13). The laws of nature rely on the human understanding of the world. They are not necessarily induced by any religious affiliations though, if they are, it is an unconscious inclination towards religious beliefs. The laws of nature relate to some of the provisions of religion. It is misconstrued that the similarity between the proclamations of the founding fathers and the ideals of Christianity imply that they were intentionally applied in reverence to God. A skeptical view of such proclamations cast aspersions on the use (Hamburger 120). It is fair reasoning that if it were a reality that the founding fathers championed Christianity, then its application could be evident in the Declaration of Independence. Natural rights are inalienable. In essence, nature dictates the best human actions. Often, the natural laws have similarities with the doctrines of Christianity (Hamburger 45). In the presence of such a similarity, individuals may be confused to believe that they subscribe to the

Cloud Computing Essay Example | Topics and Well Written Essays - 750 words - 1

Cloud Computing - Essay Example By the early 1970s, many mainframes acquired interactive user interfaces and operated as timesharing computers, supporting hundreds of users simultaneously. Data was batch processed at the end of business cycles, usually daily at night; modem speeds were slow and downloads happed when computer were more or less idle. Users gained access through specialized terminals or personal computers equipped with terminal emulation software. By the 1980s, many mainframes supported graphical terminals, and terminal emulation, but not graphical user interfaces. Graphical user interfaces reached mainstream in the 1990s through new operating systems supporting GUIs on personal computers. In the mid-2000s the word timeshare became cloud computing and was sold to new customers as a new network configuration. Cloud computing allows business to work with documents in the cloud such as word processing and spreadsheets. Microsoft office functionality for documents, calendars, and contacts can be accessed through Microsoft’s office 365 for small firms. This office offers all the requirements that may be needed by small firms in terms of word processing. Packages that are also offered by cloud computing are the full desktop version of Microsoft office that the users can download, install and use from their main computer when one is working without internet connection (Defelice 2010). Businesses can exchange accounting information and data through email cloud services, for example firms can simply buy as many mail boxes as it can and then allocate the mail boxes to the employees, and therefore the business do not need to set up and manage an email server from its premises. Google applications for work are some of the most powerful cloud email that is widely used by many companies. Another important mail service is the Gmail which is very powerful and flexible for the vast majority of small firms. Moreover, cloud email services are available from many email service

Low Phonemic Awareness Skills Among Disadvantaged Families Dissertation

Low Phonemic Awareness Skills Among Disadvantaged Families - Dissertation Example Empirical research into language use shows that there exists a wide gap between language use among children from well up families and those from economically disadvantaged families. Most children from disadvantaged families have low phonemic skill awareness compared to those from well up families. The purpose of this research is to identify ways in which the problem of phonemic awareness among children from poor background. The research will use a sample of 50 students from whom phonemic awareness skills will be evaluated. To provide credible conclusions and recommendations, this research will take a quantitative approach. Previous Research Phonemic awareness is a topic that has garnered a lot of attention among researchers in the recent past, owing to the persistent language problem that has indicated phonemic awareness weakness among many students in institutions. Dickinson and McCabe (2004) researched on the existence of phonological problems among children with a bilingual orient ation. The deduction of this statistical survey is that there indeed exist numerous factors that contribute to weakness in language among these students. Among these factors, Dickinson and McCabe (2004) identified that the standards of living played a key role in determining the success of language learning among children. Although this research was not directly designed on measurement of poverty levels, it was possible to outline the link between educated parents and a better economic social status (Koutsoftas, Harmon & Gray, 2009). The major conclusion of this research was that children who were fostered by learned parents had a better phonemic expression. Nichols et al (2004) found that Latino children and children from low socioeconomic backgrounds are more likely to fail to develop phonemic awareness and concepts in print owing to the fact that they lack preschool experience, causing them to lag behind when compared to children from different ethnicities and better socioeconomi c backgrounds. Latino children are at risk because English is not their first language meaning that they will categorize phonemes in their primary language as that is how their linguistic minds are programmed. Children from these categories are seen to either lack the prior knowledge or misunderstand the instructional discourse, along with the language of the text and teacher, resulting in delayed acquisition of crucial concepts that are in print (McGee & Ukrainetz, 2009). Notably also, findings from this study indicated that gender was not linked to development of phonemic awareness. These students require instructional intervention that looks into their needs and in a broader perspective. McDowell et al (2007) found that children, who undergo early reading challenges, receive less practice than other children, miss opportunities to develop reading comprehension strategies and are likely to have a negative attitude towards reading. Callaghan and Madeleine (2012) attributed the diff erence in phonemic awareness between children from low socio-economic backgrounds and their peers from high or middle socio-economic backgrounds to varying levels of emergent literacy. This variability is in turn explained by previous home environments, level of oral language and provision of good early intervention programs. In contrast, Neuman and Dickinson (2011) suggest that genetic predispositions

Project Part 2 Research Paper Example | Topics and Well Written Essays - 1250 words

Project Part 2 - Research Paper Example The unique design of the product means that the competition from other traditional local products in Kenya will not affect it. Kimono has an appeal to people of different age-groups. More recent kimonos cloths are of simple designs and cheap. Therefore, the poor people from all part of the country are in a position to afford kimono cloths. However, there are also expensive designs which are ideal for the rich people. Kimono also incorporates fashion in coming up with their design. For instance, young women are mostly attracted to kimono cloths because of their fashionable and appealing look. Moreover, due to the flexibility of its designs, they can be made to fit different cultural believes and practices of the various groups and communities in the country. This plays a very important role in identifying and distinguishing the different cultures (Kotler& Armstrong, 2013). Kimono also recycles its materials to produce the recycled kimono cloths. This is rare clothing that is unique and beautiful and very ideal for women aged between forty and sixty years. The element of recycling is beneficial to those whose kimono clothes would have become old, worn out and tarnished. It is, therefore, cheap and convenient considering the recycled materials can be taken back to the tailors to make other clothes, thus, saving money that would have been used in purchasing new cultural clothes at a higher cost. For example, Yukata, product of kimono, popular for the people who love casual wear. It is made from linen, or cotton or polyester which is dries quickly. This makes Yukata an ideal to be worn during the summer period because of its comfort even in worn climates. However, in order to fit in the Kenyan market, kimono will have to make a few changes in their ultimate designs. The changes would be done in a manner that will depict the various cultural practices of the different communities. There are 42 ethnic communities in

HU300 unit 8 topic 1 Research Paper Example | Topics and Well Written Essays - 250 words

HU300 unit 8 topic 1 - Research Paper Example The director explains how long it takes for a plastic bag to disintegrate and the impact it has before it actually disintegrates. The main mythic elements focused on in the film are water and earth. The effects of these elements in the film are to portray the journey of the plastic bag to the point of its disposal. Additionally, the elements are used also used to emphasize on the durability of the plastic bag. Wind is used in the film to show the motion and the journey of the plastic bag despite its will. Music in the film is used to describe the grimness that the bags undergo. However, this does not stop them from continuing with their journey. This bag in particular is lonely and seeks happiness despite the fact that it understands that such happiness is difficult to find. Eventually, the plastic bag accepts its fate and seeks to outlive everything in order to seek its

Metaphysics and Monism Essay Example for Free

Metaphysics and Monism Essay People are monists, dualists or pluralists depending on whether or not they believe that reality is composed of one, two or more substances. These positions may be represented as here indicated. Hindus, Buddhists and Animists are for the most part monists. They believe that reality is one and that everything that exists is a functioning part of that whole which is spirit. Western man for the most part may be called a monist also as he believes that God is dead and matter is the only substance to reality. Bible believing Christians would be pluralists. In philosophy of mind, monism is usually contrasted with the dualist position that mind and matter are deeply different. Thus, monism is the claim that mind and matter essentially the same. However, this sameness has come in a number of different and contradictory varieties. For example, Hobbes felt that the mental is merely and epiphenomena of the physical, thus the physical is the one real substance (Contemporary materialism is also a form of physicalistic monism (see Churchland, 1996). In direct contrast, Berkeley postulated that the physical is just a collection of ideas (hence, idealism) and thus the mental is the only thing that really exists. Finally, there are a number of positions similar to Spinozas property dualism, often referred to as dual-aspect theory. Spinoza held a position in which the mental and the physical are simply two modes of a more basic substance (it should be noted that strictly speaking, Spinoza was not a property dualist as he held that the mental and the physical were two of a possible infinite number of modes of the basic substance, nevertheless he is typically labeled as one). For Spinoza, this basic substance was God. Thus the only real thing is God, who is neither physical nor mental. Spinozas position is similar to that of Russells neutral monism, however the latter is not committed to the belief that a supreme being is the more basic substance. General Information Monism is any doctrine based on the assumption of a single underlying principle. Metaphysical monism allows that only one being or type of being exists. A substantial metaphysical monism asserts that the variety in our phenomenal experience is due to the different states of a single all-encompassing substance, for example, Parmenides Plenum or Baruch Spinozas God or Nature. An attributive monism admits many substances but asserts that they are all of the same kind, for example, atoms or G. W. von Leibnizs monads. Epistemological monism identifies that which is immediately present to the knowing mind with the real object known. Either the content of the mind is equated with the object known (epistemological realism), or the object known is equated with the knowing mind (epistemological idealism). Monism as a philosophical term was first used by Christian Wolff to designate philosophies that attempted to eliminate the mind-body dichotomy. Monism (Greek monos,single), in philosophy, is a doctrine that ultimate reality is entirely of one substance. Monism is thus opposed to both dualism and pluralism. Three basic types of monism are recognized: materialistic monism, idealistic monism, and the mind-stuff theory. According to the first doctrine, everything in the universe, including mental phenomena, is reduced to the one category of matter. In the second doctrine, matter is regarded as a form of manifestation of mind; and in the third doctrine, matter and mind are considered merely aspects of each other. Although monistic philosophies date from ancient Greece, the term monism is comparatively recent. It was first used by the 18th-century German philosopher Christian von Wolff to designate types of philosophical thought in which the attempt was made to eliminate the dichotomy of body and mind. Although he was not known by the term, the 17th-century Dutch philosopher Baruch Spinoza was one of the most influential monists. He taught that both material and spiritual phenomena are attributes of one underlying substance. His doctrine strongly anticipated the mind-stuff theory. Advanced Information Although the term was first used by German philosopher Christian Wolff (1679-1754), monism is a philosophical position with a long history dating back to the pre-Socratic philosophers who appealed to a single unifying principle to explain all the diversity of observed experience. Notable among these thinkers is Parmenides, who maintained that reality is an undifferentiated oneness, or unity, and that consequently real change or individuality of things are there? Substantival monism (one thing) is the view that there is only one substance and that all diversity is ultimately unreal. This view was maintained by Spinoza, who claimed that there is only one substance, or independently existing thing, and that both God and the universe are aspects of this substance. In addition to having many eminent proponents in the Western philosophical tradition, substantival monism is a tenet of Hinduism and Buddhism. In Hinduism each element of reality is part of maya or prakriti, and in Buddhism all things ultimately comprise an interrelated network. Attributive monism (one category) holds that there is one kind of thing but many different individual things in this category. Materialism and idealism are different forms of attributive monism. The materialist holds that the one category of existence in which all real things are found is material, while the idealist says that this category is mental. All monisms oppose the dualistic view of the universe, which holds that both material and immaterial (mental and spiritual) realities exist. Attributive monism disagrees with substantival monism in asserting that reality is ultimately composed of many things rather than one thing. Many leading philosophers have been attributive monists, including Bertrand Russell and Thomas Hobbes on the materialistic side, and G. W. Leibniz and George Berkeley in the idealist camp. The Christian intellectual tradition has generally held that substantival monism fails to do justice to the distinction between God and creature, and that of attributive monisms only idealism is theologically acceptable.

Sweatshops And The Race To The Bottom Phenomenon Economics Essay

Sweatshops And The Race To The Bottom Phenomenon Economics Essay (1.) Why do global critics often cite sweatshops as a prime example of the race to the bottom phenomenon? (2.) In addition, are sweatshops a stop on the road to prosperity? (3.) Meanwhile, are sweatshops a common ground? (4.) Finally, how can developing countries minimize or escape the dangerous abuses that often accompany foreign direct investment in low labor-intensive operations? Global critics feel that the race to the bottom phenomenon is what happens; they say when world markets are opened to free, unfettered trade. In addition without transnational labor guidelines and regulations, big corporations will look to place factories and manufacturing plants in countries with the most relaxed environmental and labor standards for multi-purpose advantages. Are sweatshops a stop on the road to prosperity? Maybe so opinions vary but, records indicate this theory. Human rights, low wages, and less protection for workers that dominate export markets, or attract the mammoth amount of share in foreign direct investment supports the previous theory. Only with the prosperity brought by international trade, globalizations adherents say, can a country then afford to demand better working conditions for its workers. This means every prosperous country today once employed child labor in its economic adolescence that would today be considered sweatshop working conditions. (Radley Balko) Do sweatshops have a common ground? At the end of the day there are at least a few areas in which both free traders and anti-sweatshop crusaders can agree. Most free trade advocates agree, for example that benefiting from slave labor is no better than theft. Sweatshop workers are often the envy of their communities they make more money than the farmhands or beggars. The key to building prosperity is choice, and if workers dont have the option to quit, or to take a job with a factory across town offering better wages, the free in free trade is a misnomer, and the benefits of globalization are tainted. (Radley, Balko) How can developing countries minimize or escape the dangerous abuses that often accompany foreign direct investment in low labor-intensive operations? The list of dangers and difficulties linked to foreign direct investor and associated subcontractor operations in low -skill, labor-intensive operations is quite long but, perhaps somewhat surprisingly, so is the list of possible benefits and opportunities.(Theodore H. Moran) ANALYSIS PART 1 (Perception of the race to the bottom phenomenon) Sweatshops are an ongoing problem throughout the global economy, especially in the developing countries. There is more than 90% of child labor and sweatshop market employed in the rural areas of Asia and Africa. Even though there are a lot of developed countries that oppose child labor and sweatshops because of moral and ethical reason. They feel that the companies are taking advantage of the developing countries and exploiting their children just to make a profit. However, the developed countries have to understand the social and economic cost, the standard living conditions, and having a good grasp of what people living in these developing countries might go through. Sweatshops might be the answer and not the problem in developing a country. Furthermore, the importance of having sweatshops is that it automatically creates jobs for the rural areas of these developing countries. These new jobs can pay up to two or three times as much of minimum wage, which gives the people more money to spend and this helps develop the country because the average income rate is rising. The developing countries will say that it is morally and ethically wrong for companies to move their business to rural and developing countries, because they are not being paid as much as developed countries. In addition, they are making their employees work 84-105 hours a week compared to the United States traditional 40 hours, and sometimes the salary is 60% 80% lower than a company will pay in the United States. Just to add, sweatshops are viewed as over working their employees causing and creating hazardous and unhealthy working conditions. How would life be in developing countries without sweatshops? Since sweatshops create new jobs and new opportunity for the people in these rural areas, without the sweatshops the new jobs and opportunity would be gone. This will lead to young women and men prostituting themselves just to make money to survive. Also, starvation will become a huge factor in the developing countries, because without any jobs opportunity for an unskilled worker becomes narrow, without an education. People will have limited choices, for example possibly starving or stealing; which overtime will lead to additive violence, and eventually raise the crime rate because people have to survive. Nevertheless, since sweatshops are in a rural area it helps monitor the crime rates, starvation, and increases the dream of education because families are given opportunity to become more skilled alongside an ample income, paving a new way for the next generation. Therefore, as we learned in our International Business class, some of the developed countries can be bias and hypocritical because developed countries previously endorsed a sweatshop opportunity to gain existence and power in the market, examples are South Korea, and Taiwan. More importantly a majority of developing countries will embrace this vicious cycle for exposure, skill, and hands on awareness of a volatile market. Analysis Part II Sweatshops and Prosperity Sweatshops are good for globalization and prosperity because of comparative advantages in the market, which help the developing countries grow in the long run. Sweatshops will give developing people in rural areas a set of skills that will help them to compete in the International market. Companies like Nike and Wal-Mart help develop these countries by giving them the opportunity to learn how to do things those consumers and companies in develop countries take for granted. In return the skills sets learned will manufacture undeveloped countries, while increasing competitiveness and assembling products cheaper but still efficient, will engage a higher demand and raise the GDP of undeveloped countries. The thought of stability supports prosperity which is rare globally, so if opportunity renders freedom of choice for developing countries the debate becomes simple and survival is usually submitted. Analysis III Are Sweatshops common ground? Common ground is usually effective if the government in the host country is held accountable in the international community. Therefore the fundamental disagreement about sweatshops revolves debate about fairness. Western companies benefit from cheap labor in the developing world; sweatshop activists say western corporations can afford to pay artificial living wages and that anything less reeks exploitation. Further arguments include corporate governments penalizing the western companies internally if better working conditions arent offered to the developed countries or consumers refraining from purchasing products. Common ground becomes a factor, globalist say if that happens western corporations have no incentive to invest in the third world in the first place. Developing countries have two choices when negotiating common ground, (1) embrace foreign investment, (2) demand wages not proportional to what their national labor market would naturally allow. In most cases, the track that delivers prosperity (1) or the track that produces continued poverty (2) will lend clues to the debate and the winning verdict. Analysis IV. FDI in low labor-intensive operations Global markets gain their questionable state of regimen through rules that are stated in trade agreements, labor laws, and factors that give constructions on gender. Once you understand markets as institutions it will allow you to link the globalization of the apparel industry to US foreign policies. Major players within in the US textile and apparel industries seem to hold different trade strategies in store for use. The textile industry benefits from rule-of-origin protections, the apparel industry benefits from free trade without restrictions. Large-scale retailers became key political players. Unions opposed free-trade arrangements with developing countries that they believe foster a race to the bottom type of mentality. Overall the previous information about trade and apparel just emphasizes the importance of growth and power in the free trade market which elaborates capitalism and the issues of transparency simultaneously. In transition, developing countries do have a strategy for attracting investors to low-wage export industries to establish special export processing zones or free trade zones. Nevertheless the objective of establishing EPZs and FTZs is to provide foreign investors and their subcontractors with freedom duties on the capital equipment and components while exempting many governments from various labor regulations in the zones, including the organization of labor unions. Foreign Direct Investment in low wage, low-skill host countries has two sides failure and success. Positive is that when FDI is implemented in undeveloped rural areas potential benefits of a new life are given such as jobs, skills, agenda, choices, opportunities, etc. Negative outcomes of FDI is that deception and bondage may be used to prevent the people from leaving their jobs; in extreme situations recruiters and agents set up networks in which family members arrange to pay off loans my selling their children into contract labor. In addition, workers may receive no benefits such as social security alongside workers being deprived promotion and benefits of seniority. CONCLUSION Analysis Part I The race to the bottom phenomenon can be viewed as an advantage or disadvantage. Most global critics tend to view corporations and retailers taking credit for offering jobs and services to a weaker opponent, but not using internal ethics as a navigator to promote a safer healthier work environment. Nevertheless youre able to see the pros and the cons but overall my opinion clearly states that globalization and capitalism at the bottom can be harsh but stability equates to balance which means development needs more pros than cons overall but we all start from an infant stage to adolescence yearning for maturity and experience. Analysis Part II Are sweatshops a stop to the road to prosperity? Yes I feel that prosperity is not just tangible riches that a person or country endures, but the intangibles that are benefited from prosperity are much greater. So the resolution is to sweatshops overall being prosperous is government ethics meaning that leadership starts from above and trickles down. To be prosperous means sacrifice, discipline, and patience, but these qualities define moral ethics and the sweatshop or the corporate retailer cant establish a culture that has to come from the developing country internally. Analysis Part III Are sweatshops common ground? This question brings joy to me because this interrogative statement revolves around the debater and their view. However I consider myself a debater so let me elaborate yes and my reasons why are this history teaches you about the past meaning you may have or not endured historical moments or events during the time line of your life; which remotely if successful allow you and your family comfort. Just to add if youve never endured something but wanted more how can you deprive a choice of opportunity to another person or country without bearing the conditions or lifestyle they represent. So my inclination of common ground is the specimen of experience and the verdict well that would be the individuals choice. Analysis Part IV How can developing countries minimize or escape the dangerous abuses that often accompany foreign direct investment in low labor-intensive operations? FDI are benefits of investors that see potential from an undeveloped country starting with lack of opportunity, few choices, skill, education, health care, and other fundamentals of a higher standard living. In addition, there are disadvantages of countries with FDI such as benefits, working conditions, employee treatment. But to minimize or escape the dangerous abuses a host country must hold the government accountable and the standards that they allow corporations to work under and the ethics and treatment that follows. Labor unions and police monitoring is a start because that enforces accountability which leads to other interest groups in the future and set a precedence of standards throughout internally which will tap the external zone/developed countries or corporate retailers. Globalization and trade derived from conditions such as sweatshops, slavery, bondage, and to enhance undeveloped countries means upgrade the conditions and the legal environment.

The Manufacturing Of DNA Vaccines

The Manufacturing Of DNA Vaccines A detailed design and layout of the facility for the manufacturing of DNA vaccines was developed. The factors foremost in the design and layout of the DNA vaccines facility were compliance to current good manufacturing practices (cGMP), regulatory guidelines, health, safety and environment, effective production, optimum material and personnel flow, effective cleanliness, minimisation of contamination and enhance maintenance. The total site area is 108m X 91m (9828m2) and plant/production area is 32m X 20m (640m2) with space for future expansion. To reduce the impact of airborne particles, relative humidity, pressure and temperature on the purity, efficacy, and safety DNA vaccines product, a containment/cleanrooms of class 100 was design with controlled-air environment with access via airlock, HVAC and high efficiency particulate air (HEPA) filters. In order to conform and comply to current good manufacturing practices (cGMP) and regulations, the following key component of cGMP were i ncorporated into the design, validation master plan (VMP), standard operating procedures (SOPs), appropriate quality control (QC), cleaning-in-place (CIP), sterilisation-in-place (SIP), trained personnel, documentation, health, safety and environment, utilities required and waste treatment process. The entire project timeline was estimated with the aid of Gantt chart project management technique to be a year and 4.5 months with reference to literatures on similar projects. 1.1 Introduction The demand for DNA vaccines for gene therapy, vaccination and for the treatment of diseases such as cancer, malaria, swine flu, HIV, melanoma, etc. is on the increase (Prather et al., 2003; Williams et al., 2009). This is because DNA vaccines triggers cellular and humoral immune responses, safe and stable (Prather et al., 2003). Therefore, there is need to design manufacturing facility for DNA vaccines production to meet the rising demand. However, the design, operations and layout of the manufacturing facility must conform and comply to standards, specifications and guidelines stipulated by regulatory authorities such as the U.S. Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Evaluation Agency (EMEA), World Health Organisation (WHO) and the regulation of the country in which the facility is to be constructed. In addition to meeting this regulations and guidelines the DNA vaccines production process, design and premi ses of its manufacture must conform to good design practices (GDP) and current good manufacturing practices (cGMP) (Shamlou, 2003; Przybylowski et al., 2007). The commercial scale production of DNA vaccines is justified by economics/cost, health, safety and environment, compliance to legal standards and production under Good Manufacturing Practices (GMP) (Shamlou, 2003). This is to ensure that manufacturing processes are controlled and performed according to design specifications and operational procedures in order to ensure that quality is built into the product (DNA vaccines) to assure safety, efficacy, purity and identity consistently (Przybylowski et al., 2007). In addition, GMP requirements are open ended, however the International Society of Pharmaceutical Engineers (ISPE) has enumerated the principal steps to current GMP which include standard operational procedures (SOPs), qualification and validation of process performance, design, quality control testing, adequate process control, sterilization in place (SIP), cleaning in place (CIP), layout design, quality management, documentation and audit of facility as necessary to ensuring specification and maintenance of product identity and compliance to regulations (WHO, FDA, MHRA, etc.) and current good manufacturing practices (cGMP) (Day, 2004). The issue of location for the manufacturing facility is crucial to its profitability as it is influenced by raw material supply, transportation, utilities, environmental impact, waste disposal, local community considerations, personnel, climate, plant size and availability of land (Sinnott, 2005). Moreover, before the design and installation of a new facility for pharmaceutical and biopharmaceutical product manufacture, an environmental impact assessment (EIA) is perform and approved (Davda, 2004). Hitherto, the design of any manufacturing facility must integrate the design of a treatment process and safe disposal of the waste generated to specified legal standards by regulatory authorities and eliminate/minimise harm to health and safety of personnel, environment and product contamination. The manufacturing facility layout must be designed to aid good raw material flow, waste flow and personnel flow around the factory to reduce risk, cross contamination and ensure that production ac tivities and factory operations are performed smoothly and follow a defined procedure. The pharmaceutical manufacturing process must be conducted in clean environment and clean rooms in which the temperature, pressure, air borne particles and relative humidity are controlled to specified conditions by regulators (U.S. FDA, WHO, ISO, MHRA, etc). All these are the component of current Good Manufacturing Practices (cGMP) to build quality assurance, consistency and safety of therapeutic product (DNA vaccines) to human life (Signore and Terry, 2008). The entire operations and activity should be performed by trained and competent personnel and quality management for a satisfactory quality assurance (QA/QC). 1.2 Aims and objectives 1. The defined goal of this project is to develop a detailed design and layout of a manufacturing facility for the production of DNA vaccines for commercial scale, applying current Good Manufacturing Practices (cGMP) and in compliance to regulatory guideline (FDA, FDA, MHRA, WHO, etc.). 2. Provide detail methods for qualification and validation of the design and layout, performance, quality control and enumerate the personnel/staff involved in the project. 3. Estimate the timeline of the project. 2.1 Process overview DNA vaccines production mainly starts on a bench scale through pilot scale to large scale production (Ferreira et al., 2000; Bequette et al., 2004). The design of a large scale facility for the manufacturing of DNA vaccines involves the selection of suitable plasmid DNA constructs/vectors (ColE1-type vectors, pUC vectors, pBR322 plasmid vector, etc.) that will replicate at high copy numbers, the production microorganism cell bank (Escherichia Coli), subsequently followed by fermentation process in the bioreactor under optimum conditions and control media (temperature, pH, pressure, etc.) to maximise cell growth, cell lysis to break the cells to release the DNA, isolation by precipitation of genomic DNA, cell debris, proteins and RNA, purification by anion exchange chromatographic technique because DNA is negatively charged, formulation and blending, sterile filling, packaging and storage in the fridge (Ferreira et al., 2000; Prather et al., 2003; Przybylowski et al., 2007).   2.2 Design of flowsheet The conceptual design of the process flowsheet for DNA vaccines production under cGMP was based on the knowledge of the process block diagram in Fig.1 above and the performance of the associated unit operations. The process flowsheet shown in Fig.2 is interconnection of the various unit operations, fermentation, the downstream processing (cell lysis, precipitation, clarification and concentration, primary purification (anion-exchange chromatography) and secondary purification (size exclusion chromatography)) and blending and formulation of the bulk product into usable form (Prazeres and Ferreira, 2004). Each pieces of equipment in the process flow sheet are designed to conform and comply with standard and code of practice of either International Organisation for Standardization (ISO), British Standard Institution (BSI), American Petroleum Institute (API), American Society for Testing Materials (ASTM), American National Standard Institution (ANSI), etc. to ensure safety, selection of suitable material of construction, and also equipment manufacturers work to produce facilities according to standardized design and size (Sinnott, 2005). Also each pieces of equipment are hygienically designed with good polished surfaces and piping for easy CIP and SIP, elimination of dead zones and sharp edges to avoid microbial growth and contamination and constructed with stainless steel material to eliminate contamination. The final product DNA vaccines are sterilely filled into vials and stored at -20oC in the freezer (Przybylowski et al., 2007). 3.1 Site layout design The site layout was designed to prevent product contamination, environmental pollution and to safeguard the health and safety of personnel. The various unit operations shown on the process flowsheet in Fig.2 and the ancillary buildings required to support the manufacturing facility for DNA vaccine production are laid out to give an economical flow of raw materials to final product storage, flow of personnel and waste around the production site to conform to good manufacturing practice (GMP), reduce risk and product contamination (Sinnott, 2005; Signore and Terry, 2008). The site layout design in Fig.3 was done with consideration to future expansion of the DNA production. Clean rooms, waste treatment area, hazardous process and raw materials were isolated and arranged for safety of product, personnel and environment. The size of the site is 108m X 91m (9828m2) as shown in Fig.3 and the ancillary buildings and support services required for the manufacturing facility are: Storages for raw materials and DNA vaccines. Quality control laboratory. Maintenance workshops and warehouse. Utilities: steam, compressed air, power generation, refrigeration, water (WFI), CO2, N2 etc. Cleaning-in-place (CIP) and Sterilisation-in-place (SIP). Effluent treatment and disposal plant. Process control room Administrative offices Fire stations and other emergency services Amenities required include: roads and car parks, first aid centre, canteen, security, rest room, changing room, training room and visitors centre. 3.2 Facility layout design The detailed design and layout of the DNA vaccines production rooms and equipment is designed to minimise risk, reduce cross contamination, permit effective cleaning and sterilisation of external and internal surfaces of process equipment by the use of clean in place (CIP) and sterilisation in place (SIP), enhance maintenance and control of clean rooms temperature, pressure and relative humidity (RH) under standard operating procedures (SOPs) (Przybylowski et al., 2007). The facility layout design also considered the cleanrooms, equipment and the flow of materials and personnel as key factors that impact on manufacturing cost, operational procedures and productivity (Drira et al., 2007). The DNA vaccines manufacturing facility layout design is 32m X 20m (640m2) in size as shown in Fig.4 to ensure efficiency and safety of the production environment and manufacturing process which are dependent on the layout of the facility (Jacobson et al., 2002). 3.2.1 Cleanrooms/containment design One of the principles of GMP is cleanliness and aseptic operations to prevent product contamination by microorganisms, particulate generated during plant operations and changes in room conditions (temperature, relative humidity, etc.). Therefore, DNA vaccines which are biological drugs are manufactured in clean rooms, that is, a room in which the air quality (airborne particles), the temperature, the pressure and relative humidity are controlled to prevent contamination by impurities, dust and microorganisms in the atmosphere and in the ambient air, in order to protect its purity, efficacy and safety (Sutherland, 2008). The layout and design of the production rooms was according to the International Standards Organisation (ISO) 14644-1 cleanrooms classification shown in Table 2 below. The raw materials, fermentation, purification, blending and formulation and product storage clean rooms are designed for class 100 biosafety cabinet fitted with high efficiency particulate air (HEPA) fi lters and HVAC systems to ensure the entry of clean air into the cleanrooms and exit of dirty air inside the rooms (Sutherland, 2008). The flow of air in and out of the cleanrooms is laminar. Other components of the cleanrooms include: Separate airlocks for entry and exit doors for personnel, raw materials and waste products. An inlet port for fresh purified air. An exit vents fitted with activated carbon filter to purify contaminated air before discharge to ensure environmental safety (Sutherland, 2008). Cleanrooms air pressure is maintained below atmospheric to prevent outward leakage. Nonslip floors, electricity, light appropriate and aseptic processing hood. Humidifiers to maintain and control cleanrooms relative humidity and temperatures 4.1 Raw materials Variations in raw materials composition is known to impact on the quality of DNA vaccines produced and also the operations of the plant. Therefore, raw materials require quality control check before used. The raw materials, reagents and utilities required for the DNA vaccines manufacturing facility are: plasmid DNA vectors, nutrients, glucose, water for injection (WFI), sterile air, salt, buffer capacity (to stabilise pH of fermentation), liquid nitrogen N2, and antibiotic, alkaline, master cell bank (MCB) and working cell banks (WCB). These are placed in the quarantine storage room and undergo quality control testing to ensure that specification are met before used for DNA vaccines production for quality assurance (QA/QC). The flow of materials from the raw materials to the final product (DNA vaccines) is shown in FIG. above and the final DNA vaccines products are stored in a sterile room in a freezer at -20oC (Przybylowski et al., 2007). 4.2 Personnel The compliance to current good manufacturing practices (cGMP) and regulatory guideline depends on people and good management structure. It is essential when developing new facility to integrate all relevant personnel from production, logistics, quality control and engineering in the inception phase of the design and layout. Therefore, for a satisfactory quality assurance of the DNA vaccines production, facility design and layout, the interactions and inputs from various disciplines such as chemists, chemical engineers, biochemical engineers, biologists, microbiologist, pharmacists, civil engineers, project managers, mechanical engineers, electrical engineers, architect, cost engineer and many others are required to carry out defined tasks and responsibilities. The flow of personnel around the designed facility layout during operations is shown in FIG. 4.3 Qualification and validation The qualification and validation of pharmaceutical manufacturing facilities at regular intervals is an integral part of good manufacturing practices (GMP). This is documentary evidence that assures that the DNA vaccines production facility is performing satisfactorily and consistently to specification for the intended purpose (Day, 2004). To do this, a validation master plan (VMP) is drawn up which include: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) to confirm that all was done according to specifications (Day, 2004; Chaloner-larsson et al., 1997). However, an internal audit of the facility and instruments is also conducted to ensure compliance and implementation of cGMP and regulatory guidelines. 4.3.1 Design qualification (DQ) Design qualification is carried on the following production pieces of equipment of the manufacturing facility such as bioreactor, centrifuge, anion-exchange chromatography, size exclusion chromatography, microfiltration system, ultra-filtration system, HVAC systems and lyophilizer, for verification and documentation as a prove to show that the equipment designs conforms to regulatory standards such as ISO 9000, BSI, etc. 4.3.2 Installation qualification (IQ) The IQ is a documented verification that confirms that the manufacturing facility layout, HVAC systems, supporting utilities (steam, CIP, SIP, etc.) and process equipment are built and installed in compliance to the designed specification and manufacturers recommendations (Chaloner-Larsson et al., 1997). The IQ document for each equipment/system contains name of equipment/system, description, model and identification number, the location, utility requirements, any safety feature, date, personnel and approver. 4.3.3 Operational qualification (OQ) The OQ is the documentary verification of the manufacturing facility to confirm that each pieces of equipment operates in accordance to designed specifications and operation conditions and will consistently (Day, 2004). This is accomplished by testing control systems, alarms, switches, and providing standard operations procedures (SOPs) for the operations of the manufacturing facility. 4.3.4 Performance qualification (PQ) Performance qualification (PQ) is a documented verification that confirms that the manufacturing facility and the supporting utilities will consistently perform to required specification under the designed operating ranges to production the DNA vaccines. The following systems and pieces of equipment are validated for performance check: purification processes, bioreactor, HVAC systems, autoclave, CIP, SIP, oven, pure steam generation system, purified water and water for injection systems, centrifuge and lyophilizer. 4.4 Quality assurance and Quality control (QA/QC) The consistent production of DNA vaccines to meet therapeutic specification of safety, purity, efficacy and potency depends on good quality assurance and quality control (QA/QC) performed by qualified persons (QP). Quality control of the DNA vaccines is one of the key component of current good manufacturing practices (cGMP) and regulatory guideline of U.S. FDA, WHO, MHRA, ISO 9000 etc. It involves testing procedures employed to check that the DNA vaccines product are uniform from batch-to-batch and raw materials used for its production meet the specification, quality and standard. The quality control testing laboratory consists of the following assays for determining quality of raw materials and product purity, efficacy and safety: High performance liquid chromatography (HPLC) to determine the percentage of RNA, supercoiled and nicked. pH meter test for residual buffer salts and alkaline. Agarose gel electrophoresis (AGE) test for plasmid DNA vaccine purity, determine RNA and genomic DNA presence in the product. Gas chromatography test for the presence of ethanol, determine plasmid size Flame ionization detector (FID) test for the presence of isopropanol in the product. Transfection/Immunofluorescent staining test for potency of plasmid DNA vaccines. Kinetic chromogenic limulus amoebacyte lysate (LAL) test to quantify the presence of endotoxin in the product Sodium dodecylsulfate polyacrylamide gel electrophoresis (SDS-PAGE) test for the quantity of proteins in the product (DNA vaccines). GeneQuant spectrophotometer test to quantify the purity of the DNA vaccines product. Bicinchoninic acid (BCA) assay quantify the amount of proteins present in the bulk product. Mass spectrometer, measuring, weighing, recording and control instruments calibrated regularly. The analytical instruments are validated to ensure performance. The DNA vaccines must meet at least minimum specification, purity, efficacy, safety and quality set by regulatory authority after sterile filling before released (Przybylowski et al., 2007; Prather et al., 2003). 4.4.1 Product testing Prior to the release of the DNA vaccines after blending and formulation, the quality control department must test each batch for purity, identity, efficacy, safety and potency using the analytical assays mentioned above, and if the result does not meet regulatory specifications the batch will not be released (Prazeres and Ferreira, 2004). Table 1 below shows an example of DNA vaccines purity and quality specification. 4.5 Documentation Documentation of all the activities and operations is a key requirement for GMP, regulatory bodies, and helpful for management structure, traceability of every batch history, planning, elimination of errors, effective communication, records keeping and design and layout of the DNA vaccines facility. Regulatory authorities such as FDA, EMEA and WHO require documentary evidence as prove that the DNA vaccines facility will perform consistently in compliance to cGMP. The DNA vaccines project documentation include: standard operational procedures (SOPs), design qualification, installation qualification, facility layout design, specification sheets for each pieces of equipment, performance qualification, quality control records, process flow sheet, site plan, personnel records, licence, commissioning, validation master plan (VMP), packaging, labelling, etc. both on paper and electronically (Signore and Terry, 2008; Sinnott, 2005). 4.6 Utilities Utilities are the support services required for effective design, layout and manufacturing process of DNA vaccines, they include: Potable water, USP purified water used for cleaning in place (CIP) to clean process equipment. Water for injection (WFI) used for media preparation, fermentation media and rinsing of equipment after CIP. Clean steam for sterilisation in place (SIP) to sterilise the process equipment after each batch. Electricity for lightening, instrumentation, analytical instrument, etc. Sterile gases such as filtered sterile air for fermentation process, nitrogen N2 for working cell bank storage, heating, ventilation and air-conditioning (HVAC) system. Refrigeration for the storage of the DNA vaccines product at -20oC. 4.6.1 Heating, Ventilation and Air-Conditioning (HVAC) System Heating, ventilation and air-conditioning (HVAC) system is a component of the production clean rooms design and layout, it plays a vital role in ensuring that the manufactured DNA vaccines product quality, efficacy, safety and purity is not impacted by room temperature, relative humidity (RH), air borne particles, pressure and cross contamination in accordance to standards and classifications of rooms by ISO 14644-1, US Fed. Std. 209, BSS5295, EEC, etc. (Zyl, 2005). The HVAC systems for this manufacturing facility include: High efficiency particulate air (HEPA) filters to control air borne particles, dust and microorganisms of the clean rooms. Desiccant dehumidifiers/refrigerated dehumidifiers are used to monitor and control the temperature and relative humidity (RH) of the rooms in order to comply with raw materials and DNA vaccines product requirement. Airlocks and air handling unit (AHU) are put in place for pressure monitoring, control and maintenance of pressure cascade with the production rooms. 4.6.2 Water and clean steam systems Purified water, water for injection (WFI) and clean steam are essential utilities generated on site and distributed for use in DNA vaccines production, clean-in-place (CIP), sterilisation-in-place (SIP), and media preparation (Robbins, 2010). In order to ensure safety, purity and efficacy of the DNA vaccines the water used for its production is sterile water for injection (WFI). The WFI is produced from purified water by distillation/reverse osmosis to meet the required standard of purity specified by the United State Pharmacopeia (USP) (pH 5.0-7.0, nonpyrogenic and antimicrobial agent). The WFI is stored at elevated temperature (80-95oC) to eliminated microbial growth, and the system constructed with stainless steel to eliminate contamination (Robbins, 2010). The WFI system design is shown in FIG. 4.7 Waste treatment and management The system for treating the waste generate from the DNA vaccines manufacturing facility is an integral part of the design of the facility, layout and good manufacturing practices (GMP). The major waste generate from the production process are genomic DNA of the host cells, RNA, proteins, cell debris, salts, endotoxins and plasmid isoforms (Ferreira et al., 2000). The waste is treated to regulatory standards (BS, ISO, etc.) to avoid harm to health and safety of personnel and environment (HSE), pollution and eliminate cross contamination of the product. The system for treating the waste is illustrated in FIG. below WWWW Incineration Autoclaved Waste Discharge Autoclave 4.7.1 Health, Safety and Environment (HSE) The DNA vaccines production microorganism poses some hazard. The environmental impact assessment (EIA) of the DNA vaccines production system therefore becomes a key part of the design and layout of the manufacturing facility (Prazeres and Ferreira, 2004). However, the environmental impact assessment (EIA) study and the design will require approval from environmental protection agency before the facility is built (Davda, 2004). To ensure that health, safety and environmental regulations are met, the process design and layout is geared towards minimisation of waste generation, safety of product, safety and health of personnel and incorporation of waste treatment process before discharge to the environment. In addition, the personnel will also be provided with personal protective equipment (PPE) such as hand gloves, gowns, goggles, etc. to work with. 4.8 Legislation and regulation The manufacture of DNA vaccines is highly regulated to ensure that it is safe, efficacious and pure for humans, and also its production carried out in accordance to current GMP (Plumb, 2005). Therefore, before the DNA vaccines can be marketed they must be licence from the relevant regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the Food and Drug Administration (FDA) in the United States, the EMEA, WHO and so on (Smith and Dennis, 2001). The manufacturing facility used for the production of the DNA vaccines must be licence too (Plumb, 2005). These licences are obtained if and only if the manufacturing facility design, layout and premises of its manufacture conform and comply to current good manufacturing practices (cGMP) and with regulatory standards, guidelines and specifications stipulated by MHRA, FDA, WHO, EMEA, ISO, etc. Hitherto, the company must also provide detailed documentary evidence about the safety, purity an d efficacy of the DNA vaccines and the consistency of its manufacturing process. Signor and Terry reported that the incorporation of current good manufacturing practices (cGMP) into good design practices (GDP) at the inception of the manufacturing facility will ensure that regulatory conditions are met (Signor and Terry, 2008). The regulatory guidelines specify the requirements for the pharmaceutical manufacturing facility, not the methods to achieving it. The regulatory bodies functions include: safeguard public health, licensing, monitoring DNA vaccines post-marketing, regulating clinical trials and publish quality standards. 5.1 Project timeline This project has a definite start, middle and end, which consist of several activities ranging from the environmental impact assessment and design approval, construction to commissioning executed in a defined order to bring the project to completion. It is the function of the project manager to plan, schedule and control these tasks/activities in a specified sequence and allocate materials, manpower, machinery and money to ensure that the project is completed on time (Gray and Erik, 2008). There are several project management techniques available in the literature, but to estimate the timeline of this project the Gantt chart technique was employed, which a plot of each task against time. Each bar represents a task/activity, length of the bar corresponds to the duration of the task and the position indicate the start and finish times. The timeline for key activities of the project are shown in FIG!!!!!!!!!!!!!! below, the Gantt chart was prepared with reference to (Davda, 2004). The e ntire project is expected to take a year and 4.5 months from the Gantt chart. 6.1 Recommendations 1. Legislations and regulations are subject to changes with emergent of robust technology, therefore the design of the manufacturing facility should be above the current specifications and standards. 2. A well defined and detail engineering drawings and specifications that does not require much interpretation. 3. A good relationship between project design team with relevant regulatory authorities and encouragement of their input will fortify the design of the facility and compliance to cGMP. 4. Ensure that all designs, installations and utilities are validated according to validation master plan (VMP) and are working according to design and specification of regulatory bodies. 5. Compliance with current good manufacturing practices (cGMP) at the inception of the design phase of the facility. 6. The DNA vaccines production facility should be designed and layout to harmonized the various regulations by different bodies such the US FDA, UK MHRA, EU, Japan, ISO, WHO, etc. to boost market for the product. 7. The process parameters such as temperature, pH and pressure must be carefully controlled to assure batch-to-batch identity in final product. 7.1 Conclusion Incorporating current good manufacturing practices (cGMP) from the beginning of the design and layout phase of the DNA vaccines facility, the production processes and to the manufacturing premises will ensure that all regulatory specifications are met.