The role of e-CRM Research Proposal Example | Topics and Well Written Essays - 1750 words

The role of e-CRM - Research Proposal Example The research questions set out for the study may not be exhaustive however the proposed research is set out to find suitable answers to these questions that will in fact help the researcher to establish a case for e-CRM and its applications for small and medium in developing countries that are currently facing tougher competitive conditions not only from the local big corporations but also foreign companies that are seeking stronger position in these markets. E-CRM that has been defined in several ways is considered to be one of the most recent developments that have given a new insight to customer relationship management by companies. One of the definitions of e-CRM states that â€Å"E-CRM uses information technologies in order to support strategically the execution of CRM. E-CRM is a combination of hardware, software, process, applications, and management commitment designed to support an enterprise-wide CRM business strategy that will optimize customer satisfaction, customer loya lty, financial performance, etc†.The role of e-CRM is considered to be of high significance for SMEs as it allows such businesses to achieve efficiencies and competitive advantage. Business can use various internet functionalities to overcome hurdles in trade and adopt an approach that is not restricted geographically and can yield better opportunities for SMEs. The use of e-CRM is not simply recording consumer data over the internet but could also be used to provide real time personalization for interaction with customers.

Distillation Column Essay Example for Free

Distillation Column Essay The components that need to be separated are 1-propanol and 2-propanol. These two compounds are isomers with fairly close boiling points. They are separated based on their physical propertis. With the battch distillation might be almost impossible to do the sepapration. Capacity of the reboiler is 20 L. The Supply of pressure and steam is regulated by a newly-established controll system consisting of a steam pressure sensor, a Fieldpoint data communication and aquisition module from National Instrument, an electromagnetic control valve, and a LabView control algorithm designed by dr. Jang. The data was taken frm one of the six computers near the column which had the control algorithm. The Fieldpoint module needed to be connected with the column via Internet. In this column at different stages there are 10 thermocouples (K type) inserted in each tray. Manual steam valve open 40%. Proportional gain or band (Kc) 2 Integral (reset) time ( Ti min) 0. 2 Derivative (rate) time (Td min) 0 Steam pressure set at 9 psig. Used Peng Robinson model Inside the column, the downflowing reflux liquid provides cooling and condensation of the upflowing vapors thereby increasing the efficacy of the distillation column. The more reflux is provided for a given number of distilaliton plates, the better is the columns separation of lower boiling materials from higher boiling materials. Conversely, for a given desired separation, the more reflux is provided, the fewer distillation plates are required as in our cases 8 plates. A reboiler at the bottom of the distillation column provides the heat needed to generate the upflowing vapors inside the column. The reboiler can be a heat exchanger. Fig. 1 The liquid feed mixture to be distilled 1 propol and 2 propanol is placed into the round-bottomed flask along. As the mixture is heated and boils, vapor rises up the column. Some of the vapor cools and condenses on the glass platforms (known as plates or trays) inside the column and runs back down into the liquid below, thereby refluxing the upflowing distillate vapor. The hottest tray is at the bottom of the column and the coolest tray is at the top. At steady state conditions, the vapor and liquid on each tray is at equilibrium. Only the most volatile with hte lowest boiling temperature of the vapors stays in gaseous form all the way to the top. The vapor at the top of the column then passes into the water-cooled condenser, where it condenses into a liquid. The process continues until all of the most volatile components in the liquid feed boil out of the mixture. When a liquid mixture 1 propanol and 2 propanol is heated so that it boils, the evolved vapor will have a higher concentration of the more volatile 2 propanol (i. e. , lower boiling point) components than the liquid mixture from which it evolved. Conversely, when a vapor mixture is cooled, the less volatile components tend to condense in a greater proportion than the more volatile components. The heated feed is partially vaporized and rises up the column. However, as it rises, it cools by contacting the descending cooler liquid and partially condenses so that, while part of vapor continues to flow upward, the condensed portion is enriched in the less volatile component(s) and flows downward. As the vapor continues to flow upward, it undergoes partial condensation a number of times and each time becomes richer in the more volatile component). The column is kept at steady state temperatures, pressures, and compositions at every point within the column are essentially kept constant during operation.

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.

First Confession Essay examples -- essays research papers

Mrs. Ryan and the Priest In Frank O’Connor’s story â€Å"First Confession†, Mrs. Ryan and the priest are different. Mrs. Ryan and the priest approach Jackie differently and have different affects on him. Mrs. Ryan makes Jackie feel like a sinner in her approach to him. She teaches him how to examine his heart by asking himself a few questions, â€Å"Did we take the name of the Lord, our God in Vain? Did we honor our father and mother? Did we love our neighbors as ourselves? Did we covet our neighbors goods?†(614). This made Jackie feel like he is a sinner because he feels that he was not honoring his grandmother and feels that he coveted Nora’s penny she got every week from their grandmother. Mrs. Ryan affects Jackie by making him feel that confession is scary. After telling her story about the ma...

Analysis of Challenges in International Management Essay

Analysis of Challenges in International Management† Abstract The following essay analysis the challenges in International Management with particular regard to the challenge of â€Å"culture† in international business as it is the must difficult to deal with and being essential for successful results in a wide range of global management tasks nowadays and in the future. Introduction Today successful international management requires more than a lot of frequent flyer miles or seasoned expatriate managers. But what are those exclusive challenges of international management in today’s world? The importance of international management is constantly increasing, as we exist in a world where globalisation is affecting the traditional borders in a broad range of areas. †¢Trade and investment, †¢Economic alliances, †¢The international stage players, and †¢The work environment are changing rapidly, being supported by the increasing sophistication and lower cost of information technology. World trade and investments are growing fast (the volume of world trade among countries has grown at an average rate over 8% since 2005 (WTO 2008)), linking the economies and creating opportunities and threats. New, strong and forced competitors are coming from developing nations in Asia and the transitioning economies of Eastern Europe. Furthermore, the constantly rising level of foreign direct investment also has a globalising effect (Thomas 2002). Moreover, the emergence of the free-trade areas drastically decreased traditional economic boundaries. So do the three largest groups, the EU, the NAFTA, and the APEC, account for nearly half of the world’s trade (Cullen 2002) and the World Trade Organization (WTO) now has 140 member-nations, aiming to reduce tariffs and liberalize trade. But globalization also affects the work environments within organizations. Changes involve cutbacks, team-based management movements and privatization. For instance, there can be factory closings, as Nokia closing their German plant in Bochum moving to Romania, because of cheaper labour. All in all, as one key consequence of globalisation, international managers nowadays have to face a more dynamic, complex, competitive and uncertain environment and need skills (as a global mindset or the ability to work with people from diverse background) not considered necessary for domestic-only managers. The environment of international management can be divided into †¢economic, †¢legal, †¢political, and †¢cultural factors (Thomas 2002). So for making decisions it is essential to understand the economic strategies of the countries in or with one wants to conduct business with, because level of economic development and quality of life differs extremely worldwide. Furthermore, there are various national sovereign laws and regulations existing in the world which have to be observed and made allowance for. And in addition, there are several varieties of political systems (e. g. , theocratic totalitarianism in Saudi Arabia), containing different levels of political risks which have to be managed. For instance, decision makers have to able to estimate the degree of risk associated with a government’s involvements in business affairs depending on characteristics of their company. All these factors present impressive challenges multinational management has to face. However, the management challenge of culture and its effects on business practices and organizations is one of the most difficult to deal with. As conducting business with people from other cultures will never be easy you have to understand how culture affects management and organizations. â€Å"Culture† is a concept borrowed from cultural anthropology and there are numerous and subtle different definitions. As each definition has limitations focussing on international management the following description of Geert Hofstede seems very helpful. He defines the culture of any society as comprising shared values, understandings, assumptions and goals learned from earlier generations, imposed by present members of a society and passed on to succeeding generations (Hofstede 2008). Culture is something shared by members of a particular group, differentiates humans from other groups, is transmitted through the process of learning and adapts to external and internal environments and relationships. The international businessperson needs to be aware of three levels of cultures that may influence multinational operations. These include national culture, business culture, and organisational cultures (Cullen 2002). National culture can be described as the dominant culture within the political borders of a nation-state. But one has to be aware that multiple cultures can exist within political boundaries and they do not necessarily reflect cultural borders. For instance, Canada being home to Anglophones and Francophones. Furthermore, even relatively homogenous cultures can have diverse subcultures, including cultural differences which are affecting the international business. Nevertheless, as most business is conducted within the political borders of a state and nations can be defined as political unities, varying in governmental, legal, educational, institutional and labour systems, influencing the way people interact with their environment (Thomas 2002), national culture has the greatest effect on international business being probably the most logic starting point trying to understand the cultural environment. Business culture, reflecting the national culture, influences all aspects of work and organizational life (e. g. , motivating staff, negotiating with business partners, etc. and knowing it’s basic requirements (e. g. , what to wear to business meetings, business etiquette is more formal in Germany than in the U. S. with conservative dark business suits, etc. ) is essential for the international manager. Moreover, especially in the last few years, people realized that the â€Å"culture†-concept also holds for individual organizations. So may differences in organizational culture may be one reason why the merger of two otherwise successful companies failed. It is important to evaluate the influence of organizational rules, norms and procedures to understand the causes of behaviour in organizations. With shared behaviours, conditional relationship, being socialized into and partly involved in it, etc. organizational culture differs in construction and elements of national culture. Even so understanding these cultural factors is fundamental for international managers conducting international business, they have to be aware that â€Å"cultures† can just offer wide guidelines for behaviour, as for instance organizational cultures differ within any national context and individuals vary in each culture level. One cannot predict exactly how each person acts, feels, thinks, etc. Nonetheless, broad generalization about a culture provides a level of analysis from which to begin to understand the cultural environment and the complexities of cultural differences, because management functions such as planning, organizing, leading, and controlling in a global economy have to account for them. As international managers have to face various cultural challenges testing their management abilities they must be able to unpack the culture concept. Therefore the basic concepts of cultural dimensions can help them understand how two or more cultures might be different. An essential implication of these frameworks referring to international management and culture is that cultural interpretation and adaptation are a prerequisite to the comparative understanding of international management practice (Morden 1995). The following sections describe two popular models. Hofstede’s Culture Model This Framework, created by dutch scientist Geert Hofstede and based on a research over 11600 people in 50 countries (starting with 39 IBM subsiadiaries worldwide), tries to evaluate how basic values underlay organizational behaviour. National differences are investigated by five dimensions of basic cultural values: 1. Power distance 2. Uncertainty avoidance 3. Individualism 4. Masculinity and 5. Long-term orientation (Hofstede 2008). 1. This first value dimension refers to how cultures deal with inequality and tries to postion the inequality acceptance level by unequal power distribution society members. In countries with a high power distance acceptance (e. g. , such as Mexico), people respect and hardly ever bypass formal hierarchy positions (Elizabeth M. Christopher 2008). 2. The second value dimension concerns about the degree humans in a society are threatened by uncertain situations. The social system of a higher uncertainty avoidance society is dominated by regulations and rules, predictabilties and orders and people tend to be suspicious of change, whereas people from lower levels of uncertainty avoidance societies (for instance, countries such as Denmark). tend to be less formal, take higher business risks and plan and structure less 3. Individualism refers to the affinity to primarily take care of oneself and one’s direct family, and then to the rest of society (with the U. S. being a good example) (Elizabeth M. Christopher 2008). 4. The fourth dimension of â€Å"masculinity† concerns about the ranking of tradionally â€Å"masculine† values in a society, such as less concerning for others, materialism and assertiveness, whereas â€Å"feminity† on the other side emphasises the quality of life and relationships. 5. Long-term orientation cultures are insistent and saving (e. g. the culture of China) and short-term orientation is more self-centered, money-oriented and more social. All these factors are inter-reliant and interactive in their effects. So shows the Anglo-Dutch example Unilever the practicability of multinational enterprises where the power distance, uncertainty avoidance, and individualism values are similar; and where the masculine achievement orientation of the British complements the people orientation of the Dutch (Morden 1995). All in all, so there is a lot of criticism (for instance, the time-dependence of the results, the non-exhaustive investigation of only one multinational US company, etc. to these findings and the model of Hofstede, it is still a very valuable and useful â€Å"gift† for understanding culture and culture-based behavior. Trompenaars’ Culture Model The model created by Fons Trompenaars its also based on the researched of value dimensions. He studied the behavoiur of 15000 managers, representing 47 national cultures (Hampden-Turner 2008). Five of the seven dimensions of his model deal with the challenges of h ow people relate to each other: 1. Universalism versus particularism 2. Neutral versus affective 3. Specific versus diffuse . Achievement versus ascription 5. Time as sequence versus synchronisation The two final dimensions deal with how a culture manages time and how it deals with nature. They include: 6. The society-orientation to the past, present, or future and 7. â€Å"Control of† versus â€Å"accommodation with† nature 1. The value of univerlism refers to the application to systems and rules objectively, without taking consideration to personal circumstances, whereas the particularism culture (e. g. in countries as Spain) is more subjective and focusses more on relationships. 2. The second, the neutral-versus-affective, value dimension refers on the emotional orientation of relationships (such as expressing your feelings and emotions more like, for example, the Portugese). 3. In Addition the specific-versus-diffus dimension investigates if people from a special culture tend to be more or less specific or diffuse in their relationships (for example, Germans try to separate work and personal issues). 4. In the achievement-versus-ascription dimension, it is asked: †What is the source of power and status in society? † (Elizabeth M. Christopher 2008) So is for instance, in an achievement refering culture, the â€Å"status† of a person mainly based on it’s individual achievement (such as job performance, etc. ). 5. â€Å"Time as sequence† orientated cultures separate events in time (â€Å"step-by-step†), whereas â€Å"time as synchronisation†-orientated indiviuals manage events in parallel. (For example, if their business partners are not sharp on time, Germans, coming from a â€Å"time-as-sequence† orientated culture, may consider it an insultation). 6. This value dimension is about past versus future orientations. 7. Moreover, this dimension refers to the extent to which individuals feel that they themselves are the primary influence on their lives. Using this framework trying to understand some culture-basics some interesting patterns may emerge. Altough, being recognised for their validity (the results of these both major studies have some significant parallels, even so they were carried out in different times using different methods and examples), these concepts of cultural value orientation proposed by Hofstede and Tropmenaar can only give a basic framework for the analysis of cultural differences. They are utensils to help understand a culture and adjusting business practices to diverse cultural environments. They are for instance, a prerequisite to the successful new-market country entry, whether by setting up licensing or new subsidiaries, joint ventures, mergers or for the establishment of efficient programmes of international HR development (Kay 1993). But international managers have to realise that the understanding of another culture is a inexhaustible learning process. They will have to practice for their international work with or in other countries by studiying all that they can about the country, including more than just the business etiquette. Understanding the national culture builds just the foundation. As you seldom can get behind the front stage of culture without speaking the national language onother basic instrument is learning the language. But the challenge of â€Å"culture† in international management takes such much more than this. International managers have to broaden their understanding of cultural differences and to learn to seek advantage in differences. Understanding the culture is just a basis for the diverse international management tasks, as appropriate cross-cultural communication (using appropiate communication styles), effective and positive motivating and leadership in international organisations and across cultures, successful negotiation with international business partners and making ethically and socially responsible decisions. Conclusion The environment of international management can be divided into economic, legal, political, and cultural factors, with â€Å"culture† being the most challenging and most difficult to deal with, influencing a broad range of management tasks. Providing oneself with the necessary knowlegde and understanding of the national culture of the country or the people one is conducting business with is essential and builds just the foundation for the successful complementation of global management tasks, such as for instance leadership in multinational organisations (where you have to have understanding of all three levels of culture; national, business and organisational culture, being different and influencing each other).

New future Essays

New future Essays New future Paper New future Paper Safie had been taught by her mother to aspire to higher powers of intellect and an independence of spirit. (CH14-p124) In a similar way the Monster also has ideas of improving his education when he discovers three books in the woods, (CH15, p127 ) these possessions of these treasures gave me extreme delight, I now continuously studied and exercised my mind upon these histories. One of the books is the story of paradise lost. Victor resembles Satan from Miltons Paradise Lost, in which Satan is an archangel punished for his vanity, arrogance, and thirst for forbidden knowledge. Like him, Victor attempts to take over Gods role as creator. Mary Shelley is perhaps suggesting that Victor should be punished for his acts as she doesnt show Victor in a positive light. It raises questions about what is natural and unnatural and highlights the struggle between science and God. It ultimately asks What is human nature? Is it human nature to question God and go against him, as Adam and Eve also did? The monster that Victor creates identifies both with Satan and with Adam. The Monster was not born evil or with the intent to do harm and violence to others, but throughout the novel his emotions overtook his mind, and he committed diabolical acts against others. He compares himself to Adam when he says: Like Adam I was apparently united by no link to any other being in existence (CH15p129) He goes on to say: Many times I considered Satan as the fitter emblem of my condition, for often like him when I viewed the bliss of my protectors the bitter gall of envy rose within me (CH15 P129-130) This shows his passionate hatred of man against him. He has been reduced to a low level, despite the fact that he has done nothing wrong. May Shelley makes the reader feel pity for the creature and makes you question your judgement on what is a monster. The Monster secretly watches closely and is educated in history, politics and religion at the same time as Safie is tutored. The monster says, My days are spent in close attention that I might speedily master the language, while I improved in speech I also learnt the science of letters as it was taught to the stranger and this opened before me a wide field for wonder and delight (CH13-p18) . The words close attention shows that he craves knowledge and the words delight is deliberately put in by Shelley to show the parallel between the monster and Victor within their thirst for knowledge and attitude to education. The effect of this is the beneficial information that allows the reader to be able judge the characters and actions that follow. To conclude, this book has many meanings and messages- I think some of the most important are: always have an open mind, things are never how they seem, be kind as everything has on a knock on effect/ what comes around goes around ECT. Despite the books age it still holds the same morals as they both applied back in the Victorian ages. When the revolution of the steam engine and the beginning of Modern day science was rapidly progressing, people were sceptical to these new ideas and most of them were beginning to question the old ways and were looking forward to a new future