Berkshire Partners Bidding For Carter Essay Example

Berkshire Partners Bidding For Carter Paper Berkshire Partners, which h had extensive experience investing in the retail and manufacturing sectors, was initial ally drawn to o Carters because of the strong brand name night of the senior the co many had developed during d its 136 -year history y, as well ass for the street man augment team m. (See Exhibit 1 for a profile of Berkshire. ) TO o investigate the t option off a potential LOBO, Berkshire assembled d a five-member beer team, to b be led by managing directors Ross Joy ones and Bra Adele Bloom and senior associate Mice hall Occasion. (See Exhibit bit 2 for biographical sketches. The tea am would have eve less than eight weeks to o move thro ugh all the stages of a Goldman Cashled auction -?from initial research and due diligence to valuation and bid strategy. In addition to running the auction and thereby serve ins as Carters agent, Go Olden Caches (GAS) would d be offering g staple-on financing. Under this arrangement, the he winning b bidder would d have the pop option to final once the deal the wrought a prep packaged capital structure proposed by Goldman Cash. L Carters ca arties was of mounded in 18 865 in Amended, Massage hugest. Over the course o of 136 years in the highly y competitive apparel industry, the company became the largest branded d manufacturer Of toddler and baby apparel in thee United Estates and also a leading make Kerr of young ACH Aldens clothing. Divide ding its mark et into five segments-?Ia eyeteeth (i. E. , n newborn), baby sleepwear, baby play wear, young g childrens sleepwear, ND young childrens play. N. wear-?the com many sough HTH to outfit children for the first six yea ears of life, fro mom birth to buy In the early 199 ass, the company found itself struggling g. We will write a custom essay sample on Berkshire Partners Bidding For Carter specifically for you for only $16.38 $13.9/page Order now We will write a custom essay sample on Berkshire Partners Bidding For Carter specifically for you FOR ONLY $16.38 $13.9/page Hire Writer We will write a custom essay sample on Berkshire Partners Bidding For Carter specifically for you FOR ONLY $16.38 $13.9/page Hire Writer Owned at the time by in insurance com many Mute al Benefit Life and Wesley y Capital Corp.. , Carters h had developed unprofitable blew product line ones in swimwear and UN underwear, and d many of its more decorative features (zippers, cue UT bows, etc. ) were not well w received by b consumers. In 1 992, thee company installed a new w management NT team led by y CEO Frederick J. Row an, with the intention of steering it back to its core niche off soft, comfortable 1 Moor gang Stanley had recently made a similar offering to the eventual b buyer of Dresser Equipment Grog pup-?underwriting SSL . Billion in debt financing after leading the he auction. While staple-on financing was not a typical practice, , it was becoming nag more common professor or Malcolm Baker and a Research Associate James Quinn, Global Research G Group, prepared this case. HOBS cases rare developed solely as the basis Orr class discussion. Cases are not intended to serve as endorsements, e so urges of primary dat a, or illustrations of effective or ineffective management. Copyright get 0 2005, 2008, 2011 President and Fellows of Harvard College. To rod deer copies or request permission to reproduce materials, call 1800-5457685, write Harvard Business School Publishing, Boston n, MA 02163, or go to http://www. H hobs. Harvard. Due. No part of this pub publication m or by any mean may be reproduced, stored in a retrieval system, used in a SP broadsheet, or transmitted in any form ins-?electronic, mechanical, hotfoot opining, recording or o otherwise-?with hoot the permission n of Harvard Busing news School. This document is authorized for use only by Skylark Fang ([emailprotected] Com). Copying or posting is an infringement of copyright. Please contact [emailprotected] Org or 800-988-0886 for additional copies. 205-058 Berkshire Partners: Bidding for Carters clothing. 2 Rowan arrived with 39 years of experience in the industry, most recently running the Bassett-Walker and Lee Jeans division of IF Corporation. Many members of his executive team were also former managers with IF Corporation. With a strategy of simplifying Carters products, Rowan and his team returned to producing what they called high-volume, basic apparel. Product design remained relatively consistent from year to year: About two-thirds of the apparel was carried forward from season to season with the same fabric and construction, varying Only through color and artistic layout. Rowan and his team also focused on improving the capabilities of their supply chain while exploring offshore sourcing options. Throughout the compass history, it had relied on domestic manufacturing to produce its clothing. Bu t amidst an increasingly global environment in which more and more U. S. Impasses were outsourcing production abroad, Rowan sought cost improvements and manufacturing flexibility through manufacturing abroad. In 1 992, Carters closed two of its domestic sewing plants and made plans to close six additional sewing plants and its main textile mill. Central America and Mexico soon became the companys first international production sites. By 1996, with operating and financial performance beginning to turn around, Carters was acquired in a leveraged buyout by Investor S. A. , the Bahrain-based firm est. known for its investments in Gucci Group, Asks Inc. And Tiffany Co. Investor (see Exhibit 3 for profile) paid approximately $208 million. This included $56. 1 million in senior debt and $90 million in subordinated debt. The purchase was consistent with the firms philosophy of injecting patient capital into North American and European companies; this simply involved waiting for the busines s to improve before selling it or taking it public. At the time of the Investor LOBO, Carters was doing business with over 400 wholesale accounts, including department stores, national chains, and epically stores. It had also established a major domestic presence with its outlet stores: The company operated roughly 150 retail outlet stores across the country. Consumers could purchase Carters merchandise through these outlets stores at a deep discount, with the outlet stores offering new products, holdovers from excess inventory, as well as assorted Carters brand accessories and licensed products. Beginning in 2000, Carters launched a new brand called Tykes. A departure from its two mainstay brands, Carters and Carters Classics, the Tykes brand was aimed at the discount channel. Its introduction coincided with a series of conversations with executives from Target, an emerging general merchandise retailer. Target was interested in expanding the stores offerings in baby and childrens lifestyle clothing. With the assurance that Carters could keep its shelves automatically replenished, the companies struck a long-term deal in which the Tykes brand was made immediately available at all 972 Target stores across the country. By the summer of 2001, Rowan seemed to have Carters on a path of operational and financial SUccess. From 1992 to 2000, the company increased venue at a compound annual growth rate of 9. %, with earnings before income, taxes, depreciation, and amortization (EBITDA) increasing 22. 1%. (See Exhibit 4 for selected financial. ) Analysts attributed much of the comma NYSE growth to improved brand recognition, a lower cost structure, expansion into the discount channel, and the movement of some manufacturing operations offshore-?while recognizing Inves tor as an able and willing partner in managing the growth. 2 Chris Rough, Investment Bank Buys Morrows William Carter Co. , The Atlanta Journal-Constitution, November 1, 1996. ([emailprotected] Com). Copying or posting is an infringement of copyright. Please contact [emailprotected] Org or Up for Sale In mid-2000, having watched over the growth of its investment in Carters, Investor decided it was time to sell its stake in the company. Investor typically looked at a range of exit options, but at the time the initial public offering (PIP) market was at a near standstill. In Joneses view: Investor might have been able to take this company public in 2001. But they were at the end of a five-year period, and they wanted liquidity. So to sit there, take another year or two to work their way out of a public stock was not something they wanted. He added: Theyve [Investor] got a network of investors that fund them, but if you dont have good returns coming out to keep talking about, it makes it harder to raise money. So in the normal course they were looking to generate a win through the sale of Carters. Amidst rumors that a handful of potential strategic buyers had passed on the deal, including apparel companies Jones Apparel and SSH Gosh Bogs, Investor initiated an auction among financial buyers. Christopher OBrien, a ember of Investors management committee, added: The nature of this companys business is that it is not particularly related to economic swings. We thought it was a company that financial buyers would find attractive in this marketplace. 3 Berkshire Partners Berkshire Partners was founded in the mid-sass by five individuals committed to creating a private equity firm based on successful relationships, hard work, analysis, and the open decision making of all individuals. 4 By 2001 , the firm comprised roughly 10 managing directors, 4 principals, 12 investment staff (associate level), and 2 advising directors. In a given year, the firm reviewed some 1,200 potential deals, with the intention of whittling the pool down to five to six closed deals. Jones estimated the number of times per year the firm completed full due diligence and submitted a final bid at about 12: Our batting average is pretty good-?we tend to go all the way on things we think we have pretty good odds of winning. So were not making a run at 40 things and getting five. Were doing it on 10-15, and we might get almost there on another handful. For each deal under serious consideration, Berkshire formed a deal team comprising our to five people. A managing director served as lead partner for each team. A team would typically contain an additional managing director, a principal, and one or two investment staff. According to Jones, As a firm, our work is very inclusive and collaborative in our efforts to uncover all the key information. While the deal team took responsibility for making a recommendation and then doing due diligence and bringing back an investment package, ultimate investment decisions rested with the firm as a whole. In analyzing a potential deal, Berkshire relied largely on its internal staff to array out the analysis and would use a Pain and McKinney to help us answer or flush out a couple of issues that we just dont have the resources to do. Beyond that, the firm relied on leading Boston law firms to carry out due diligence on contracts, leases, patents, and trademarks. Ernst Young (EY) handled the firms accounting due diligence, which principally involved looking at quality of earnings. According to Occasion, getting the capital structure right was an art, not a science. He added: There are a lot of factors that go into determining the right financing structure. To st art, theres arches price-?dollars needed to ultimately buy the company. And, of course, there are your 3 Kelly Holman, Berkshire Buys William Carter Co. The Daily Deal, July 17, 2001. 4 Berkshire Partners Web site, Our partnership, http://www. Breathlessness. Com/l_o_partnership. SHTML, accessed December 1, 2004. 3 returns. Obviously, if I hold purchase price steady, and increase my leverage, my equity returns will increase, and so on. Berkshire managers believed the equity portion of the capital structure at the time needed to be at least 25% in order to achieve the desired ratings outcome and demonstrate to the lending ease that Berkshire Was making a serious commitment. At the time, investment banks were willing to lend at a rate of roughly four to five times EBITDA, with the multiple determined largely by market conditions. Occasion continued, This is coupled with the challenge of asking yourself: Is this the appropriate amount of leverage for a business of this type; what do the ratings look like; how difficult will it be to get the financing completed; and what does that mean in terms of your total financing costs? These are all the variables that you play with to try to figure out the optimal capital structure for the business. After taking an equity position in a private business, Berkshire saw its role as supporting management in a variety of ways, including a) helping to prioritize key objectives, b) reviewing organizational design, c) helping to build the bench of key managers, and d) even leading the integration process in the event of a subsequent acquisition. Jones added: would say that weve done a lot of work over the last several years to be more thoughtful about how to address opportunities for companies up front and align strategically with management. So in thinking about how we add value, it is important to look t the work we do in due diligence not only as critical to making a smart investment decision, but also a critical foundation to operate from during the life of the investment. At any given time, Berkshire held a portfolio of roughly 25 investments. About half of these businesses required very little of Berkshires management attention-?the firm was on top of these businesses and fully expected to exit them in due course. About one-quarter of the businesses required a moderate level of attention, and another one- quarter required Berkshire to be very focused on them. Businesses earning the largest amount of attention did so because its the early stages, or we could still have a meaningful impact and theyre very important to our firms success. Berkshires typical exit strategy was sale of the company, rather than an PIP, by a ratio of about four to one. The firms conditions for exiting via an PIP were threefold: 1) a strong brand, 2) strong growth potential, and 3) a dramatic need for capital. Unlike many other private equity firms that often used an PIP to close out their ownership stake, Berkshire was more likely to initiate an PIP in the middle of its ownership with the intention f staying involved with the management and helping the company to grow. In many cases, a follow-on offer would ensue. Berkshires Bid for Carters When Berkshire Partners received an invitation to participate in the auction for Carters, the investment team was initially optimistic about a potential match between the two organizations. The firm had developed a focus on building strong, growth-oriented companies in conjunction with strong, equity-incanted management teams. 5 Berkshire viewed Carters not simply as an apparel company in the retail space, but more as a consumer products company. According to Jones, Carters being a really Strong brand that could be leveraged across multiple channels was something that we found very appealing, and in general find appealing. 5 Berkshire Partners Web site, Press Releases, http:// www. Irrationalness. Com/5_1 _ 17_press. SHTML, accessed September 1, 2004. 4 ([emailprotected] Com). Copying or posting is an infringement Of copyright Please contact [emailprotected] Org or Initial Meeting On the first Tuesday of May, Berkshires five-member team traveled to New York to meet with Carters management. The Carter team included the CEO, resident of marketing, executive vice president of operations, executive vice president of global sourcing, and SCOFF. The meeting provided an opportunity for the respective managers to get to know one another, to discuss the ground rules for the auction, and to begin a dialogue about the future growth strategy for Carters. To a person, the Berkshire executives were very impressed with the Carter team, acknowledging their experience, commitment, and confidence in their five-year plan. (See Exhibit 5 for four elements of growth strategy. ) The initial meeting also opened lines of communication between Berkshire ND Goldman Cash, which Carters had engaged to run the auction process. In the early weeks of May, Berkshires team had a number of discussions with Goldman Cash. The deal was being shown to a limited number of financial buyers (more than 2, less than 10), and not all potential buyers would be given the opportunity Berkshire had been given to meet with the management team prior to submitting a preliminary bid. In addition to running the auction, Goldman Cash was providing staple-on financing for the deal, although the buyers were not limited to the Goldman financing Truckee and could choose to submit a bid that would be financed by other sources. (See Exhibit 6 for proposed capital structure. Members of the Berkshire team acknowledged that a staple-on financing structure, if not actually compared against competing offers in the market, could create a conflict Of interest for an investment bank. A banks dual role of auctioneer and financier, if unchecked, could pressure a buyer to accept inferior financing terms in order to win the bid. Occasion stated: Th ere were a lot of tensions inherent in the new staple-on structure. The investment banks ere concerned externally about how it would affect their reputations, and the private equity guys werent that excited about it. They felt it limited their ability to get an edge in the bidding process by bringing more creative financing to deals. What the staple-on did provide, however, was generally a more expedited financing process. Nevertheless, the Berkshire team came away from the meeting in New York eager to look carefully into the deal. In the ensuing days, Goldman furnished Berkshire with a summary of financial projections put together by Carters management (see Exhibits AAA, b, and c). GAS also indicated that the process required potential buyers to submit equity bids of at least $130 million to be considered.

Magnesium oxide Essays

Magnesium oxide Essays Magnesium oxide Paper Magnesium oxide Paper I cant have only 1 point connecting to zero to make a line of best fit because it would not be a very reliable line. Analysis The type of graph I have is as straight line in a positive correlation. The results are directly proportional which means as the mass of magnesium goes up, the mass of magnesium oxide goes up. The ratio is a constant ratio would always stay the same as long as the magnesium ribbon gets a constant supply of the same amount of oxygen every time throughout the whole experiment. This is because there are more magnesium atoms for oxygen to join with. The formula for working out the slope is: My equation was: This shows that the magnesium oxide which I have produces is Mg3O2 because 1. 44 (gradient of Mg3O2) is the closest match to my gradient, 1. 5. You cant use anything like half an atom so magnesium would lose 2 electrons and give them to oxygen and because they would become ions the structure of the molecule would be an ionic bond in a giant lattice. I used the points 0. 00 because it would be the easiest to deal with. The gradient links directly to the increase in product because it shows a positive correlation continuously. Evaluation The things that prevented or could have prevented our results from being reliable and accurate are these: * Lifting the Lid from the crucible How this affected our results is that while lifting the lid some smoke would be released into the air and that smoke is magnesium oxide and because there is magnesium oxide being released into the air that means there would be a reduction in mass which also means that we would get the wrong result for a particular length. Why we had to lift the lid was so that we could check if the reaction stopped and to let oxygen in so that the reaction could continue well. How I could make sure that this does not happen is by tilting the lid enough so that I can see if the reaction has finished and I would only tilt it for a second so that very, very little smoke get released. * Layer of Magnesium Oxide on the crucible The effect if this is that it would increase the mass of magnesium oxide we record because there is extra magnesium oxide that was not cleaned off. This would cause our results to be unreliable because it would almost be like we have made a product without anything is apparently (according to scientists) impossible. How I could prevent this from happening is by making sure that I clean the crucible so that any if any magnesium oxide was left in the crucible it would be removed. Or we could just use a new crucible. * Other formulas for magnesium oxide There uncountable numbers of possible formulas, so out of all the possible formulas there are there is a low chance that the formula that my data shows it could be may not be it, so this makes my conclusion unreliable. How we could improve our accuracy for this is by taking more records of other formulas and their gradients. * Unstable balance This would have an impact on my results accuracy and reliability because the balance kept on changing due to vibration from tables being hit and by wobbling the table which cause the balance to be unstable for quite some time. Why this is affecting our results is because we cannot be sure if the readings we have recorded are reliable because we recorded them while the balance was unstable. A way in which we could avoid this from having an effect on our results could be by isolating the room during the time we take in the results so that there would be minimal vibrations travelling through the table and floor. * Distance between the crucible and the flame from the Bunsen burner How this can alter my results accuracy is by creating less magnesium oxide because if the distance between the two are to long then there would be less heat reaching the crucible but this would only impact our results if the distance between the two was different each time because for each tests the impact of the affect would be the same. Cutting magnesium ribbons in right lengths inaccurately This would affect my reliability by giving me incorrect readings for each mass because when recording the mass I would be recording a result which would be completely of scale if the lengths were cut very accurately. How I could prevent this from happening is by using a ruler, stretching out the ribbon and cutting the ribbon with appropriate and accurate equipment e. g. scissors. E=MC2 This comes into effect in my experiment because before measuring the crucible we needed to wait for the crucible to cool down otherwise the heat would cause an increase in mass. So we would wait for the crucible to cool down before weighing it as energy is mass and mass is energy regardless of form of energy according to the theory behind E=MC2. If I dont wait for the crucible to cool down then my result would appear that the magnesium oxide as been formed from a higher mass of magnesium. Not just oxygen reacting with oxygen In the atmosphere there is not only oxygen, oxygen is only 21% of the atmosphere, 78% is nitrogen so what would also be made is magnesium nitrate. This would mean that some of my results could be unreliable because I dont know exactly how much nitrogen oxide has really been made in there is also nitrogen attached to magnesium. What I would do is remove the nitrogen by adding water. This would then create magnesium hydroxide and what I would do to change it to magnesium oxide is by heating it. I would not say that my results are very reliable because of the formula that I have create was Mg3O2 but logically it should be MgO because the correct ratio would 24:16 in mass terms and in the terms of the number of atoms from each element joining up against each other should be 1:1 and this is only because magnesium would lose 2 electrons to get a full shell and the oxygen would gain 2 electrons to get a full shell to make an ionic bond in a giant lattice. Another reason why I would say that my results are quite unreliable is because there were a lot of problems which caused the test to be quite unfair which was the lack of oxygen so what we did was we lifted the lid several times to get some oxygen in, but by doing that it lets some magnesium oxide out which would cause an accidental decrease in mass. But when looking at my graph and ignoring the gradient being 1.5 all my points on the graph are either or very close to the line of best fit and the average points dont scatter and the error bars are mainly small which indicates that my results are accurate, theyre just not very reliable because I did not get the formula MgO. I am confident that my results are accurate but Im not confident enough to believe that my results are reliable because when looking at the logical ratio it should be 24:16 but mine is 72:32 in atomic mass terms. Which does not really make much sense because naturally an atom would want a full shell but in this case only 4 out 5 atoms in the molecule are getting full shells, so I would believe that my results are very unreliable and when looking at what possible formulas there are, there really are loads which means that the formula which I have is very unlikely to be true, in fact many different formulas could have been made during just one test for one length. The method which I have used was quite accurate because of the equipment which we have used. One very accurate equipment which I used was the digital balance (0. 01g) and that was very accurate because it was able to measure the small changes in mass. The Bunsen burner was also good to use because it gave a constant supply of heat at roughly the same temperature throughout the experiment. The pipe-clay triangle made your results accurate because it made sure that the crucible was placed securely on the tripod and it also made sure no heat was blocked for the crucible. A method such as waiting for there to be no change in mass was an accurate method because it was easy to see if there was no change in mass. Overall, my whole experiment is not very reliable my results are very accurate, according to my graph. Show preview only The above preview is unformatted text This student written piece of work is one of many that can be found in our GCSE Patterns of Behaviour section.

Get a Life...and a Career Essay Example | Topics and Well Written Essays - 500 words

Get a Life...and a Career - Essay Example Career planning is an important stage in life of every high school student, and it usually starts from setting development goals and self assessment. Speaking about myself, my possible future career is teaching in college or university. As "education is the most powerful weapon which you can use to change the world" (Dunkan), I would like to make my own contribution to giving the knowledge and skills to other people, who will use them to create their own lives and careers. Besides, the profession coincides with my personal characteristics, as I like to get acquainted with other people, communicate with them, be with them, be aware of what is happening in the world, ask and answer the questions. In addition, I like to look for new materials, read interesting books and learn news on different topics, which is important, if I want to write my PhD dissertation and keep my lectures up-to-date with the changes in the world. I understand that to become a good professor, I need to work hard and spend a lot of time, before I gain experience and knowledge to teach. However, the time spent for preparations will pay off in future. And there is a place for further development in the career, as I may become engaged in research work, take part in conferences, exchange programs, trainings, write and publish books. My future goals and plans are the following. During the first 10 years I will be working hard on finishing a college, taking part in students exchange programs, entering a post-graduate course, writing a dissertation, starting my research work, establishing contacts with other researchers in my field of knowledge, and starting to work. In 20 years I see myself as an Associate Professor of a University, teaching several courses to students. I take part in different conferences, publish articles, and cooperate with foreign professors and researchers. This is also the time, when I want to settle down

The limit of shipowner's liability towards the shipper Essay

The limit of shipowner's liability towards the shipper - Essay Example The seller (shipper) will not usually make the contract of carriage with the carrier directly. What normally happens is that a forwarding agent will be employed to make the necessary arrangements. Similarly the carrier will employ a loading broker to obtain cargoes for him. The COGSA incorporates an international convention called the Hague-Visby Rules which attempt to strike a balance between the different interests of carriers and cargo owners. However there is an opinion that these Rules are weighted too much in the favour of the carrier. Therefore another set of rules, The Hamburg Rules came in force on 1st November 1992. So we have the situation where some countries have agreed to become signatories to the Hague-Visby rules, whilst other countries have adopted the Hamburg rules. The UK is not a signatory to the Hamburg Rules. Indeed it is true that the carrier may limit his liability under the COGSA because it creates a one year statute of limitation to bring forth maritime claims, and it allows a stipulation limiting the carrier’s liability to a certain amount, for example. The aim of the COGSA is to limit the liability of the carrier as insurer and to promote maritime trade in view of the many, often unpredictable perils of the sea. The principle of the Himalaya clause was developed in the British case Adler v. Dickson, 1 Q.B. 158 (C.A.1954), where a passenger, Mrs. Adler, injured on the steamship â€Å"Himalaya†, sued master and boatswain in tort because she could not sue the carrier, which was contractually exempt from all liability. The passenger won the case because the contract between her and the company did not have a clause extending the exemption to master and boatswain. Generally, a "Himalaya clause is any clause in a Bill of Lading which seeks to extend to non-carriers any immunity, defense, limitation

Embedded Systems Applications Essay Example | Topics and Well Written Essays - 1250 words

Embedded Systems Applications - Essay Example Below is the algorithm that was used to generate the test cases. The SAT solver was used to explore all the possible assignments and they are then converted to test cases. The methods that are in use are capable of generating a wide coverage for the requirements of any given specification. The filtering technique can be used to extract the most efficient test cases that satisfy the existing pre conditions and post conditions. From the design above of the embedded system, the following weaknesses can be identified: 1.There is an existing challenge in constructing a real time system that incorporates both real times in terms of both time and output. 2.The test generator may not have the capacity to deal with and handle the compositions of the subsystems. In order to make the system more efficient, a number of measures can be proposed to make improve the system. 1.Improve the methods of automatic test generator test sequences so that they are obtained automatically based on a testing go al. This can be achieved by use of TGSENS to improve the quality of the embedded system. 2.The use of scalable test generators can also improve the performance of the system. 3.The application of model checking techniques. From the discussions above, the design of an embedded system calls for a sequential creation of a model that creates a model using programming languages such as MC51 and then testing it before implementation. This has been achieved and from the results of the test case, the system can be improved in any way seen appropriate.

EHS Standards Evaluation

EHS Standards Evaluation EH S Evaluation: The product should be evaluated with respect to environmental health and safety, such as handling instructions, personal protective equipment’s and deactivating agents should be determined and made available to every personnel who are making contact with the product. Depending on nature of product, the studies are performed to validate the deactivating agents and procedures. Although it poses additional cost and timing to technology transfer, but it is the first line risk assessment for technology transfer with intending of protecting those who will be producing the product. However during technology transfer the EHS system should be maintain standards across the company. The EHS standards to be maintained for the technology transfer are as follows: Management  Systems Standards These Standards provide the framework for EHS risk management, incorporating many key elements to successful EHS management such as regulatory compliance, risk assessment, communication, self-audit, and senior leadership engagement. Risk topic standards This group of documents sets expectations for management and control of many important EHS programs including workplace safety, occupational hygiene, fire and life safety, and environmental impact reduction. Program standards These standards address the key program areas , such as office safety, contractor safety, EHS risks from suppliers of material and services Raw material specifications: The raw material may seem like basic element in the manufacturing process but it can often provide most difficulty and unforeseen delays during technology transfer. Within the pharmaceutical industry there is a great emphasis on designing quality into a product by monitoring and controlling what is delivered for manufacture of the product meets the requirements for what is needed for manufacture of the product. However the material standards should meet according to their relevant regulatory bodies, but not to be excessive because this leads to the cost and potentially cause delays for technology transfer while waiting for superfluous testing results. Analytical Method Transfers Transfer of analytical methods should accommodate all the analytical testing required to demonstrate compliance of the product to be transferred with the registered specification Analytical methods used to test pharmaceutical products, starting materials, packaging components and cleaning (residue) samples, if applicable, should be implemented at the testing laboratory before testing of samples for process validation studies is performed A protocol defining the steps should be prepared for transfer of analytical methods. The analytical methods transfer protocol should include a description of the objective, scope and responsibilities of the specification of materials and methods; the experimental design and acceptance criteria; documentation (including information to be supplied with the results, and report forms to be used, if any); procedure for the handling of deviations; references; signed approval; and details of reference samples (starting materials, intermediates and finished products) Avoid pit balls during Analytical method transfer: The exchange of the relevant method information and subsequent compilation of the transfer protocol avoid a lot of foreseeable problems during method transfers. Nevertheless potential mistakes should be reviewed. These include 1) The calculation of the results. Calibration standards and correction factors Rounding Integration parameters(eg: minimum area, threshold, noise) Reporting imits, summation or averaging procedures 2) Availability of reagents, samples, and standard material. 3) correct shipment and storage. 4) Equivalent equipment Qualification, procedure and acceptance criteria Materials and carry over properties Temperature ranges Equipments: Equipment’s are a critical part of the transfer process. For technology transfer, technical information of products as well as those of manufacturing equipments are important. To establish equipments conforming to GMP, it is essential to obtain and understand information from RD process so that quality assurance of subject drugs can be secured and the equipments can comply with required conditions for manufacturing. For that purpose, the following technical information should be transferred. The RD department should clarify considerations of GMP compliance specific to subject drugs and manufacturing methods (manufacturing processes), and present them to a facility and equipment department. The facility and equipment department should establish facilities and equipments reflecting the above considerations, clearly details of the establishment and operational considerations of those facilities and equipments, and present them to a drug manufacturing department. The drug manufacturing department should fully understand the above information, implement validations, perform appropriate operations and controls in conformity to the established facilities and equipments, and records results of operations and controls. All systems need to be ready before validation batches can be produced. Systems checklist, agreement on acceptance criteria and commercialization, stability plan, agreement on annual revalidation and approval of the transfer report must be complete to move to the Process Validation. A systems checklist with quality assurance approval provides necessary documentation that was gathered in the transfer. This should include vendor audits, cleaning validation (residual solvents), Melamine requirements addressed, equipment qualification completed with operational ranges. BSE/TSE addressed, specifications and SOPs approved. Once raw materials and packaging components are released, the transfer final report is approved. With batch records approved, risk analysis complete, and stability protocol approved, Trackwise systems are set up. Documented evidence of all required systems is placed in a file. This file is then reviewed by QA prior to signature of the Validation protocol. The decision to commercialize validation batches is made by senior leadership based on a modified risk assessment. Included in the commercialization risk assessment are a review of the product trending report, a review of the process gap assessment and discussions with regulatory. The commercialization strategy also needs to meet the January 2011 FDA guidance for product commercialization. The stability protocol includes stability requirements for each of the countries the product will be marketed. This may require rental of stability chambers or space in stability chambers for years as the diverse stability requirements are reviewed. The stability protocol may also include expectations for product stability results in relation to commercialization. Looking ahead, planning needs to include agreement on annual revalidation and filing activities. Execution of the validation plan needs to follow the agreed plan. Typically a daily update meeting will be held to provide updates from the previous days activities and ensure all systems are a go for the daily activities. The validation team needs to act accordingly when issues occur. All deviations from the plan must be clearly identified and tracked for root cause analysis. System controls are intended to cover normal operations, external events need to be handled with facility policies and be included in the validation final report. Documentation Hundreds of GMPdocuments are required for process transfers. The Code of Federal Regulations provides a listing of expected documentation including: raw material and component documentation logbooks batch records laboratory records distribution records A complete list can be developed utilizing the process maps (see Gate 4) and standard documentation sets.Once the list is made, divide the documents into groups.Remember raw materials documents will probably be required first, but finished product testing protocols often require finished goods test procedures to be validated prior to accepting the product. The project schedule should provide insight into when documents will be required. The quickest way to complete the transfer is to reformat records from the sending site, but this practice often leads to non-conformances and issues because there is a lack of understanding content and history. Each document needs to be built with the foundation process map identified in Gate 4 and utilizing Subject Matter Experts (SME) identified as part ofGate 2.The control of the critical process parameters (CPP) must be understood and the control strategy needs to be included in the documentation to ensure product attributes are achieved. Agreement on terminology and format with quality and regulatory units helps ensure standardized documentation, which allows employees to follow repeatable processes.Each document should have a dry run with personnel who have not been exposed to the process, the related SME and a documentation author (if necessary).Pictures often help, but authors need to be mindful of what is in the background. For example, I once had a formulation tank CIPprocedure written with pictures taken in the tank manufacturers parking lot. Finally a document review team is formed with appropriate representation to ensure content is consistent with expectations.Often document reviewers lack the process understanding to assess technical details but can provide oversight for other requirements.The documentation tracking sheet should monitor status and escalation needs to occur if a maximum of two revision cycles is not achieved.

Ballroom Dancing :: essays research papers

Have you did something that you didn’t really want to do, and then later get selected for doing it? Well, I have. It was another beautiful Friday at Spottsville Elementary School, and ever Friday at Spottsville was music class. But today we didn’t have music class, today was something totally different. Our music teacher Ms.Belcher was having try-outs for Mrs. Benson's ballroom dance team. To tell you the truth, I was just going to get up there and goof-off, and that I did do. But, on that Friday something went wrong, something terrible, something I didn't expect to happen. "Now class take your seat. Today we will be trying out for ballroom dancing. Only the best dancers will be teaching the 5th graders for Mrs. Benson," said Ms. Belcher. Well, I thought that it was going to be boring (which it was), and I was mad because we all had to try-out (which we all did). Ms. Belcher picked the first group and then walked over to her boom-box and started playing the Macarena. This was simple; everyone knew how to do that dance. About ten min. into dancing, my friends thought it would be funny for someone not to know how to do the Macarena, and just do something totally different. So they dared me to, and like the comedian that I am, I agreed. When she called up for the last group (which I was in) everyone was laughing, including me. I did do something totally different from the Macarena, I did the disco. Even I can’t believe it now, but I was. If I was in the audience and could see myself dancing, it would have probably looked like something off the movie â€Å"Boogie Nights†, starring John Travolta. And I know I would have been laughing too. Finally Ms. Belcher turned off the music and said, "Now class settle down. I will have the results for you sometime next week." At the end of class when we all leaving everyone was telling me how funny it was, but you could tell that Ms. Belcher did find it amusing at all. But I don’t care, as long as I got a few laughs (well it was more than a few). That following week I was sitting in Mr. Adkin's class, my regular teacher. He was showing us how to fractions, when someone knocked on the door. Mr. Adkins walked over and gladly opened it. Mrs. Benson stepped in the room and told us why she had came. Then one bye one she called people out into the hallway.

Advantages and Disadvantages of Indian Population

Free sample essay on Population Problem in India. The population problem is one of the burning issues being faced by the country. It surmounts all the problems of the country. The rapid population growth is often referred to as population explosion. The population of India has risen dramatically during the post-independence period. The increase in population is due to the spread of health care facilities thus resulting in the fall of death rate. Within a period of a little over half century, population of India has tripled to cross one billion marks.It is predicted to surpass China by 2030 to become the highly populated country in the world. The unprecedented population growth has contributed too many problems such as poverty, unemployment, food problem, housing, clothing which are the basic necessities of life. These things are directly related to the quality of life. The rising population has outpaced all the development and technological gains. It has nullified all our achievement s in the field of industrialisation. Despite all the progress made even one-fourth of India’s population is still living below poverty line.Even they do not have the bare necessities of life available to them. Millions of people have to go to bed without food. Starvation death is frequent in India despite being self-reliant in food production. Population growth is witnessing geometrical progression. The resources of subsistence are increasing in arithmetical progression. India has to accommodate sixteen per cent of total world population in 2. 3 per cent of total land. The pace of our population growth is horrifying. Forty-four children take birth every minute.Our population is rising by 2. 9 per cent per year. Thus every year an extra 26 million people are added to the existing population. Availability of better food, better hygiene and above all modern facilities in medicines, surgery and health care have caused longevity and decline in the rate of mortality. It has further aggravated our population problem. The government is taking stern measures to check the Population. It has started the family planning as early as immediately after the independence. It was the first country to introduce family planning.But the programme failed to bring desired result. So it is the need of the hour to realise the menace of population growth. Our society needs to be made aware of its dangers. The NGOs and media should come forward to create awareness in terms of population growth. We as aware citizens should change our mindset. Failure to check further increase in population may have disastrous effects. A mass awareness programme should be launched through radio, TV and other press media. The masses should be properly educated to the advantages of family planning.

Modernist Art in Europe essays

Modernist Art in Europe essays Modernist Art in Europe 1910-25 by Robert l. Herbert Herberts thesis of his essay is to investigate the arrival of the machine and modern art and its complexities. During WWI, modernist painting and sculpture paid major attention to machinery, science and industry. Modern art during that time has become a central factor in our culture due to its dominance in public art, museums, media and literature. Herbert brings in background information and stated the avant-garde of Pisarro, van Gogh, Monet, Renoir, etc. The industrial revolution had a stronger grip on society during the 19th century, and during this time, modern art was associated with primitive nature. During the rise of industrial art their was a rise of landscapes and paintings of rural everyday life. Also, the new technique and style which became the handcraft to modern art was so avant-garde from the academic art. Modern art was involved with cubism, futurism and vorticism. He explains that all of these arts consisted of the importance of handcraft, creativity, individuali ty, and original expression. Herbert keeps bringing in the fact the machine was the leading sign of modernity. There was no more of a gap between handwork and the machine. Also, that the machine became so important in modern art because it was now a part of daily urban life, due to subways, telephones, automobiles, sewing machines, bicycles, televisions, cinema, and more advanced photographic and advertising developments. Herbert states that although the machine became a large factor in art that it was not incorporated in the work of all modernists, such as Picasso and Braque. The author then describes the modern art in epic cubism, and how it focused on geometric architecture and structures of mechanical parts with organic rhythm of daily life. And how Italian futurism dealt with modern city life, but with more immediacy, more implied movement. It was similar to cubist but with more calc ...

buy custom Sexual Orientation essay

buy custom Sexual Orientation essay Gender determines the type of jobs one is able to get and work on females are the grade school teachers as opposed to male principals in high schools in fact some states dont allow males to teach grades lower than the sixth grade (such a nationality favors males). Female doctors are so few with some states having even less than five gynecologists and in the military they add up to 2 percent these being mainly nurses (Richards, 2000). This makes females to be of a lower financial class as compared to males. Females also are not at free will to choose whether to become lesbians, as they will not be recognized. Both Amy Richards and Lisa Weiner-Mahfuz bring multiple identities forth and they consider identities such as class, race, skin color, sex orientation, nationality among others. According to Richards, the young women and girls have restrictions in their activities. For example, they cannot play soccer or form teams. Besides, having sex determines their chances of getting stable future partners. It is also evident that females cannot get most services without male escorts signatures from their husbands; they are denied bar or restraint services or important operations on their bodies without their consent. Generally, sexism is a form of discrimination due to sex. However, in the case of these authors, this is different. For instance, Lisa shows that class, race, religion (anti-Semitism) and sex orientation (lesbianism) all affect sexism. This author strongly brings out the confusion amongst mixed-class, mixed-religion, mixed-race people can undergo especially when the character could not know where to be classified between the white (she has a white complexion) and the colored. Often confusion is mixed with anger and a feeling of rejection. Feminism is encouraged by the author as a form of dealing with racism and general oppression. Buy custom Sexual Orientation essay

Hinduism Essay Example | Topics and Well Written Essays - 500 words - 2

Hinduism - Essay Example The paper will discuss the religious beliefs that are practiced by Hindus as well as their dialogue. Beliefs and dialogue One of the fundamental beliefs among the Hindu community that distinguishes it from other religion is its definition of the â€Å"meaning or purpose of life† (Oppenheimer, p. 1). While other religions’ primary objective focuses on allegiance to a supernatural power, Hinduism’s definition the purpose of life balances allegiance to the supreme authority and the need to fulfill bodily desires. Depending on a person’s level in life, the religion defines different goals to be pursued at every stage. The purposes of life at respective stages as defined under the religion include the need to achieve an individual’s purpose. As a result, the Hindus believe that every individual exists for a particular purpose and that purpose should be fulfilled in the person’s present life, before death. The religion also believes that every indi vidual has a defined level of personal success that should be pursued and achieved. Similarly, every Hindu is entitled to fulfill personal desires that include â€Å"enjoyment, sexual and other desires† (Oppenheimer, p. 1). The religion’s definition of life further provides for personal intellect among its believers. These beliefs distinguish Hinduism religion from other religions that puts emphasis on the supreme power rather than on the believers.

Emerging Trends Case Study Essay Example | Topics and Well Written Essays - 250 words

Emerging Trends Case Study - Essay Example Technical courses require creative thinking in science subjects which is the main obstacle to success to most students. Fear for science subjects has highly contributed to this problem to many candidates. Constant rise of trade schools all over America for students who are not good enough to join colleges for further studies has contributed a lot for shortage in vehicle assembly industries. The rise of trade school makes most of the students not to have vision of being a technician in future. They therefore, end their dreams in businesses (Prosser, 2009). However, most of the technicians industries are managed by aged people creating no room for the young people. The need of strong learning background in to qualify to be an automotive technician has created fear to students. Increase in wages to the workers working in industries may solve this crisis but to some extent. (U.S. Atomic Energy Commission, Oak Ridge Associated Universities.,& Southern Interstate Nuclear Board. 2014)Due to increase wage, majority of students will have an aim of meeting the demands of qualifying to be a technician due to better pay due to demand for money to most youths. However, most of the students have developed fear of doing science subjects completely. In summary, there is a need for the government to ensure that every institution is entitled to offer a compulsory science subjects to students to foster the level of awareness to science related courses. U.S. Atomic Energy Commission., Oak Ridge Associated Universities., & Southern Interstate Nuclear Board. (2014).  Nuclear related technician demand and supply: Southern Interstate Nuclear Board Region, 2013. Washington?: publisher not