Archetyple Heros Essays - Jungian Archetypes, Fantasy Tropes

Archetyple Heros In literature, the term archetype refers to a pattern or model of an action, a character type, or an image that recurs enough in life and literature to be considered universal. Medival heroes and modern ones share many characteristics; however, their approaches to dangers are quite different. First, the medival hero is thought to be brave. He goes out questing in search to set bad to good, rescue damsels in distress, and instore the chivalric code Might for Right. Next, the hero is often aided by the supernatural. He has the use of magical powers, wizardly weapons, and unearthly people. Sometimes in these stories, the supernatural being such as wizards, psychics, aurgers, and dwarves becomes the heros mentor or advisor. Finally, the hero does not deal with ordinary people. Usually he is serving or rescuing kings, queens, nobles, or other knights. However, the medival hero under the code of chivalry practices morality and other religious practices. The medival hero is often a symbol of good versus evil. He is highly honored but very humble. Finally referring back to the chivalric code, the medival hero does not go whacking away but instead uses his might for right. Like the medival hero, the modern hero James Bond is considered brave. He is sent out on dangerous missions rescuing women and innocent people, recovering top secret information, and stopping the villian. Next, he is aided by technology. James Bond uses state of the art, high tech gadgets and weapons to assist him on his missions. Also he is aided by many technological geniuses such as Q and Felix. Finally, James Bond does not deal with normal people. He is usually saving the world from a wealthy madman, serving the Queen of England, and rescuing rich and famous women. However, James Bond follows the code of the government. Under this code, there is no required practice of religion or morality. In all of his movies, James engages in sexual intercourse numerous times. James Bond is also thought more of a sex symbol. He is a young, strong handsome man that most everyone wants to be like. Last, James Bond is licensed to kill. This means he can kill whoever gets in his way and most of th e time he does. Medival heros and modern ones share many characteristics; however, their approaches to dangers are quite different. The term archetype is a pattern of character type that recurs enough in life and literature to be considered universal English Essays

Free Essays on Hamlet Vs Oedipus

In the play Hamlet: Prince of Denmark, a young prince is in search of the truth behind his father’s murder. At first, Hamlet sees the ghost of his deceased father and it tells him he was murdered by the now current king, Hamlet ¡Ã‚ ¦s Uncle Claudius. Hamlet has to think about how he will get revenge for his fathers death, but because his only knowledge came from a ghost that only Hamlet heard speak, he is hesitant to get his revenge quickly. Hamlet does everything he can to show others the truth he knows. It is important to Hamlet that he gets revenge but he also wants to torment the king and show everyone the truth. Hamlet knows his anger toward his Uncle may cause confusion in his judgement of the truth so he is hesitant to kill him right away. Hamlet second-guesses himself throughout the play only to end up dying, but not before he kills Claudius. In Oedipus the king, a child is born to a royal couple, this king and queen want to know how their child will be in the future. So they ask an oracle to tell them the future and it tells them he will kill his father and marry his mother. They have the child taken away to be killed, so they save themselves, but instead the child ends up in a new castle and is raised by another couple as their own child. They never tell Oedipus that he is not their own. When Oedipus hears he is to kill his father and marry his mother, he leaves his parents and searches for a new residence. Except he meets up with a man on the road and kills him. He then finds a castle that is being terrorized by a sphinx and answers the riddle it asks. He then marries the Queen and rules over the kingdom. In the end, the city is threatened by a plague that the oracle said will cease when the city gets rid of the one who murdered the king, Oedipus announces that the murderer will be punished. However, while searching fo r the truth Oedipus discovers that he is the murderer and the son of his wife. In the end, Oedipus finds h... Free Essays on Hamlet Vs Oedipus Free Essays on Hamlet Vs Oedipus In the play Hamlet: Prince of Denmark, a young prince is in search of the truth behind his father’s murder. At first, Hamlet sees the ghost of his deceased father and it tells him he was murdered by the now current king, Hamlet ¡Ã‚ ¦s Uncle Claudius. Hamlet has to think about how he will get revenge for his fathers death, but because his only knowledge came from a ghost that only Hamlet heard speak, he is hesitant to get his revenge quickly. Hamlet does everything he can to show others the truth he knows. It is important to Hamlet that he gets revenge but he also wants to torment the king and show everyone the truth. Hamlet knows his anger toward his Uncle may cause confusion in his judgement of the truth so he is hesitant to kill him right away. Hamlet second-guesses himself throughout the play only to end up dying, but not before he kills Claudius. In Oedipus the king, a child is born to a royal couple, this king and queen want to know how their child will be in the future. So they ask an oracle to tell them the future and it tells them he will kill his father and marry his mother. They have the child taken away to be killed, so they save themselves, but instead the child ends up in a new castle and is raised by another couple as their own child. They never tell Oedipus that he is not their own. When Oedipus hears he is to kill his father and marry his mother, he leaves his parents and searches for a new residence. Except he meets up with a man on the road and kills him. He then finds a castle that is being terrorized by a sphinx and answers the riddle it asks. He then marries the Queen and rules over the kingdom. In the end, the city is threatened by a plague that the oracle said will cease when the city gets rid of the one who murdered the king, Oedipus announces that the murderer will be punished. However, while searching fo r the truth Oedipus discovers that he is the murderer and the son of his wife. In the end, Oedipus finds h...

ALQAIDA TERRORIST ATTACK ON NEW YORK CITYS TIMES SQUARE DURING THE Essay

ALQAIDA TERRORIST ATTACK ON NEW YORK CITYS TIMES SQUARE DURING THE ANNUAL NEW YEARS EVE CELEBRATION USING CONCEALED IMPOVISED SPRAYING DEVICES TO DELIVER AN - Essay Example This forms the backdrop for this paper, which weighs the pros and cons on whether the al Qaeda has the motivation and capability to develop and use bio-weapons to carry out its mission of terror. A significant portion of the paper builds up the view that there is such an inclination, and that the likeliest targets are major US cities. The strongest candidate may be New York City, the possible terror attack to coincide with the traditional celebration of New Year's Eve. Part of the reasons is that in all the post-9/11 celebrations, the hundreds of thousands of Americans who joined the revelry came to challenge the terrorists to do their worst, invoking their sense of patriotism and hatred for terrorism. This constitutes a temptation that terrorists may not be able to resist. The most important section of the paper then sketches the possible actions that New York City and the federal government would take if and when such a bio-terror attack takes place. It also evaluates the wisdom and sufficiency of the preventive measures that the city and federal governments were compelled to undertake in the aftermath of 9/11 and the 2001 anthrax scare. Among the questions we want to address is the preparedness and capabilities of the city and federal health systems to deal with a large-scale bio-chemical attack, which represents the new threat to world peace and security that the world's health and defense systems have little familiarity as yet. Can the authorities act with efficiency and dispatch to minimize the loss of lives and confine the damageChapter 2 - Biochemical Weapons Biochemical weapons appeal to terrorists for three reasons: 1) they are easier and cheaper to acquire than nuclear devices and cause more casualties; 2) their effects on target population are hard to detect and counter; and 3) the threat of their use causes fear, which element the terrorists love most. The use of bio-weapons actually goes back to the siege

Try to defend dualism as a viable philosophical position. Entertain Essay

Try to defend dualism as a viable philosophical position. Entertain objections to your arguments and reply showing how dualism c - Essay Example Dualism is the concept that declares that the brain is not everything and that there is a mind that exists apart from it. In fact, the idea of dualism has extended from metaphysics to religion, psychology and phenomenology. Dualism is not only about the physical and the nonphysical; it is also about good and evil, mental states and outward behavior, as well as neural connections and physical action. One of the arguments for dualism is the Knowledge Argument, or the idea that the physical and mental substances seem to have properties which are irreconcilable, or that the mental substances have properties that can never be reduced to physical forms. Thus, as the goal of the Knowledge Argument is to argue for the existence of the â€Å"irreducible [and] immaterial nature of the mind† (Robinson), then it is an argument for dualism. In a thought experiment that demonstrates the validity of the Knowledge Argument, a scientist who is deaf from birth has learned all the perfect scient ific understanding of the mechanism of hearing, but when this scientist undergoes an operation to restore his hearing, â€Å"it is suggested that he will then learn ‘something’ he did not known before† (Robinson). ... It is true that the knowledge one has of hearing, such as its anatomical and physiological aspects – or â€Å"how to hear,† can be reduced to the physical and can be proven by physical experiments. Nevertheless, â€Å"what it is like to hear† can only remain mental and the existence of such somehow prove the validity of the Knowledge Argument and of Dualism as well. However, one objection to this argument is the idea that â€Å"physical concepts [such as â€Å"how to hear†] and phenomenal concepts [such as â€Å"what it is like to hear†] are cognitively independent† (Nida-Rumelin). Based on the previously discussed thought experiment, it is possible for the scientist to know phenomenal hearing or â€Å"what it is like to hear† simply from knowing the physical concept of â€Å"how to hear.† This therefore means that â€Å"what it is like to hear† is actually an entirely different piece of information from â€Å"how to hea r† and thus the former cannot be regarded as the irreducible mental property of the latter. My reply to this objection is that although the physical may be considered different from or unrelated to the phenomenal, the mere fact that the phenomenal is distinct from the physical is a proof that there are indeed two aspects of something: the physical and the nonphysical. The objection presented against dualism is weak as it simply evades the issue by criticizing the connection between the physical and the phenomenal. Aside from the Knowledge Argument, dualism is also argued for by the validity of predicate dualism. Predicate dualism is the concept which states that â€Å"psychological predicates are not reducible to physical

Finanical Planning Final Study Case Example | Topics and Well Written Essays - 1250 words

Finanical Planning Final - Case Study Example Moreover, in most cases budget building opt for simplicity where budget construction relies on simple tools like excel spreadsheets, software programs and the manual way of pen and paper (Hussey, pp123-167). The sole objective of budgetary control is to map out whether there is need to redirect your finances towards selected priorities or rather dreams you consider important. Budget making always tends towards a goal such as buying a home, trip vacation, the budget helps one finds out the discipline he needs to squirrel away finance within a certain time limit. Personnel ought to reflect on a goal to be accomplished and resolve to make it come true. Majority of the populace have no clear idea on the amount of money they spend on dining out, gifts, clothing, travel and other personal care (Hussey, pp123-167). Always track such kind of expenses in specific ways and come find out actual monthly allocations for every category Susan works at Wal-mart as a cashier on the day shift (38 hours a week @ $12 hour 38 hours is full-time and Susan recently received a $0.50 per hour raise). Susan files her taxes under filing status Head of Household Medical insurance is pre-tax and covers Susan and the children 10% per month Susan considers that this is most important expense each month (Maynard, pp167-223). She will not eliminate or reduce this $82000 and 26 years remaining; 5.25% interest; original balance $87,000. Current appraised value $88,000 For Jeffrey will need to pay this until age six of balance $2200 with credit limit of $3000 and 12.6% APR with a balance of $16,000 Standard payment plan; 6.8% APR. All Direct loans of -$10,000 subsidized and $6000 unsubsidized Susan shops mainly at Aldi and buys off-brand food Susan drives a paid for 2000 Ford Escort with 92,000 miles on it. She wants to become an elementary school teacher. She has 18 credits to finish up. She did all previous credits at Columbia College in Elementary Education. Operating income in households

Analytical Test Methods in Downstream Processing

Analytical Test Methods in Downstream Processing Andrea Waldvogel Validation of Analytical Test Methods in Downstream Processing Introduction Quality, safety and efficacy are the main principles of quality assurance of biopharmaceutical drug products. Quality must be designed into the product or process since it cannot be tested into it. Therefore, a quality system must comprise of validation, change control, training, quality control and vendor assurance amongst others.1-3 An effective validation does not only provide a high degree of confidence that the finished drug product consistently and reliably meets all quality requirements but also leads to economic benefits by reducing the cost associated with process monitoring, sampling and testing.4 Biopharmaceutical companies must perform facility, utility and equipment validation/qualification, process validation, computer and computer systems validation, cleaning validation and analytical method validation.5 This project report will focus on analytical method validation, also referred to as analytical procedure validation. Analytical methods are developed to measure characteristics such as molecular identity, purity, potency, and safety of raw materials, in-process samples and final drug products and to monitor the manufacturing process. The number of tests should be adequate to show manufacturing consistency and the impact of changes on the quality of the drug product. All methods must be demonstrated to be fit for their intended purpose before they are employed.5,6 Analytical method validation means establishing documented evidence that provides high degree of assurance that a specific method, and the ancillary instruments included in the method, will consistently yield results that accurately reflect the quality characteristics of the product tested.7 This report begins by providing an overview over some of the regulations and guidelines related to analytical method validation. The second section introduces the modern lifecycle approach to method validation and section three gives an insight into analytical method validation in biopharmaceutical downstream processing. The final section concludes the report with a summary of the main points discussed. There are many different regulations, guidelines and pharmacopeial monographs concerned with analytical method validation. As it would go beyond the scope of this document to write about all of them, the report focuses on some to give an overview. 1.1 Regulations Validation is based on, but not prescribed by regulatory requirement. It is best viewed as an essential and integral part of Good Manufacturing Practice (GMP) for the assurance of quality. Compliance with validation requirements is necessary for obtaining approval for clinical trials and to market new products.4 In the U.S. for example, 21 CFR Part 211.165(e) states8: The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with  § 211.194(a)(2). 21 CFR Part 211.194(a) (2)8: A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (à ¢Ã¢â€š ¬Ã‚ ¦). The suitability of all testing methods used shall be verified under actual conditions of use. The requirement of validation is also implied in 211.100(a)8: There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 1.2 Guidelines The first guidance documents on analytical method validation were published in the 1990s. In the course of time, a lot of revision activity has taken place allowing the incorporation of new approaches to science. The harmonised ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology guideline, issued in 2005, is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures and has tended to take on the role of a regulatory expectation. In the United States, it has been used as a guidance along with the related compendial documents USP Analytical Procedure Validation, Analytical Procedure Verification, and Analytical Procedure Transfer. However, those documents do not provide support for the users to accurately understand and control sources of variability.6,9 In 2013, a Stimuli to the Revision Process paper on Lifecycle Management of Analytical Procedures published by the USP Validation and Verification Expert Panel proposed a Quality by Design (QbD) approach to method development, validation, and performance verification of an analytical method via a lifecycle concept. They suggested that the traditional approaches outlined in the U.S. Pharmacopeial monographs , , and should be revised and assembled into a single new general information chapter Lifecycle Management of Analytical Procedures and a new general chapter specifying the basic requirements. This would, for the first time, formally link method development and method validation within pharmacopeia.6,10 In 2016, a general chapter prospectus on The Analytical Procedure Lifecycle was posted on the U.S. Pharmacopeial Notices and a draft of a new USP General Chapter Statistical Tools for Procedure Validation was published in the U.S. Pharmacopeial Forum (U.S. Pharmacopeial Convention).11,12 In August 2017, a new general USP Chapter Validation of Compendial Methods will become official. This is an effort to better align the validation concept with the revised FDA guidance for industry Analytical Procedures and Methods Validation for Drugs and Biologics issued in 2015. However, instead of including a section on Lifecycle Management of Analytical Procedures only a reference has been added. Depending on the development of the chapters and , USP may be revised again.13 Growing awareness that the implementation of an analytical method with adequate quality steps designed into the procedure during the development phase led to the development of a lifecycle approach for analytical procedure validation.10 2.1 Stages of the Modern Lifecycle Approach The modern lifecycle approach is based on the Quality by Design (QbD) approach outlined in ICH Q8(R2) guideline and defines activities and deliverables for every stage of method validation. The following diagram provides an overview. Figure 1: QbD Approach for Analytical Methods 2.1.1 Stage 1: Procedure Design, Development, and Understanding To be able to design quality into a method to ensure that the method is reliable and meets the analytical target profile (ATP) defined at the beginning of this stage, an understanding of how the procedure works is key. Risk assessment should be undertaken to identify variables that could have an influence on the method. The knowledge of variables and their impact is not only important for the development of a control strategy but also for the determination of a design space. The design space will reduce the amount of revalidation work considerably when the method is used operationally. Key elements of this stage are shown in Figure 1 no. 1-3.10 Proper method development including the evaluation of robustness is essential for an effective analytical procedure.10 Robustness is a measure of the methods capacity to remain unaffected by small variations in method parameters and provides an indication of its reliability during normal usage.9 At this stage, system suitability parameters are established which help to ensure that the analytical method remains valid whenever used.9 Without developing a robust method and an understanding of how a change of key parameters will impact its performance, the actual method validation step will be difficult.10 2.1.2 Stage 2: Procedure Performance Qualification The lifecycle approach uses the term procedure performance qualification instead of method validation. Procedure performance qualification is the verification of the performance of the analytical procedure (either a new one or a revised procedure) against the requirements of the ATP.10 If the procedure development has been done correctly, this step should simply be a confirmation that it is fit for the intended purpose. In cases where further controls need to be added to ensure reliable results the analytical control strategy, developed during stage 1, will need an update.10 Method validation work should be performed by a user laboratory under the same conditions as it will be used to comply with existing GMP regulations.10 2.1.3 Stage 3: Implementation and Continued Procedure Performance Verification This stage involves checking how the procedure works during operational use and that it remains in a state of control.10 For this purpose, inputs on reliability and performance of the method gathered from operators and customer complaints will be evaluated. Performance indicators such as system suitability, quality control samples and out-of-specification (OOS) results are tracked and trended.10 The method should be continually improved through corrective and preventive action to reduce the number of out-of-specification (OOS) results. Any change to improve the overall performance needs to be assessed using change control procedures. As shown in Figure 3, the nature of the change specifies what actions have to be taken.6,10,14 Figure 2: Change Types and appropriate Actions 2.2 Traditional (Current) Approach vs Lifecycle Approach In their Stimuli to Revision paper, the USP Expert Panel recommends the adoption of a lifecycle approach for the management of analytical procedures. In their conclusion, they outline the advantages of a lifecycle approach by comparing it to the traditional (current) approach to analytical procedure validation (Figure 1).6 Downstream processing in biopharmaceutical manufacturing involves many steps from recovery over purification to fill finish. Next to in-process monitoring of process parameters such as pH and temperature, analytical testing for the determination of quantity, identity, strength, potency, purity (product- and process related impurities), bioburden and endotoxin has to be performed on raw materials, intermediates, drug substances and finished drug products. Some of the analytical methods in downstream processing are HPLC, gel electrophoresis, PCR, ELISA, Bradford, hemagglutination (HA) and plaque assay. All critical steps in a process have to be validated and less critical steps have to be under control. The criticality of an analytical method is determined by risk assessment. There are various ways to perform method validation. The manufacturer is responsible for choosing the suitable validation procedure and justifying it.1,7,9 3.1 Types of Analytical Procedures The four most common types of analytical procedures are identification tests, qualitative and quantitative tests for impurities and assay. Assay involves the quantitative measurement of the major component(s) in the drug substance and drug product.9 3.2 Team Selection The validation project manager is responsible for the selection of a Cross-Functional-Team (CFT) from various related departments and functional areas. He or she is also in charge of assigning responsibilities and assuring that all personnel involved are trained properly.7 3.3 Analytical Method Validation Protocol The first step in method validation is the preparation of a protocol that defines the work to be done to demonstrate that the method is fit for its intended use.7,10 The analytical method validation protocol should contain the following sections: Purpose Short description of what is to be accomplished Scope of the project specifying the test methods and products Overview General description of the test method Summary of the characterisation studies Identification of method type and validation approach Test method applications and validation protocol Intended use of each test method application Analytical performance characteristics for each test method application Resources End user laboratory where the method validation is to be performed Equipment and materials to be used in the method validation Special instructions on handling, stability, and storage for each material Appendices References, signature, and a review worksheet for all personnel Specific tasks for all personnel and documentation of their training Listings of all equipment and software necessary to perform the method validation Document and materials worksheets used in method validation Test method procedures (SOPs) Before the method validation can begin the protocol must be agreed upon by the CFT and approved.7 3.4 Performance Characteristics Tests Performance characteristics and their acceptance criteria are defined during the characterisation studies at the development stage of the analytical method. Depending on the method and its intended use, some performance characteristics tests may be omitted, the number of replicates may be increased or reduced, or acceptance criteria may be adapted. All decisions have to be based on scientifically sound judgment. It is important that well characterised reference materials, with documented purity, are used for testing performance characteristics.7,9 The following table outlines the performance characteristics and their meaning, test procedures, how data should be reported and acceptance criteria according to ICH Q2(R1) and FDA Guidance for Industry on Analytical Procedures and Method Validation. Accuracy Closeness of test results to the true value For drug substances, accuracy measurements are obtained by comparing test results to the analysis of a standard reference material or to a second, well-characterized method. For drug products, accuracy is evaluated by analysing synthetic mixtures (containing all excipient materials in the correct proportions) spiked with known quantities of analyte. Guidelines recommend that data be collected from a minimum of nine determinations over at least three concentration levels covering the specified range. The data should be reported as the percent recovery of the known, added amount, or as the difference between the mean and true value with confidence intervals (such as  ±1 SD). Acceptability criteria are defined by end users but rarely fall outside 97-103% of the nominal value. Statistical analysis can be applied using a one sample t-test. Precision Degree of agreement among test results when the method is applied repeatedly to multiple samplings of a homogeneous sample Precision is commonly described in terms of repeatability, intermediate precision, and reproducibility: Repeatability is investigated by analysing a minimum of nine determinations using the same equipment and sample, covering the specified range of the procedure, or a minimum of six determinations at 100% of the test concentration and reported as percent relative standard deviation (RSD). Intermediate precision refers to the agreement among the results from a single laboratory, despite potential variations in sample preparation, analysts, or equipment. Reproducibility refers to the agreement among the results from different laboratories. Results are reported as % RSD, and the percent difference in the mean values between the analysts must be within specifications. Less than 2% RSD is often recommended, but less than 5% RSD can be acceptable for minor components. Specifity Ability to measure accurately and specifically the analyte of interest in the presence of other components In drug assays, specificity takes into account the degree of interference from other active ingredients, excipients, impurities, degradation products, or matrices. In chromatography, it ensures that a chromatographic peak corresponds to a single component. Specificity can be demonstrated by the resolution between peaks of interest. Limit of detection (LOD) Lowest concentration of an analyte in a sample that can be detected In a chromatography laboratory, the most common way to determine both the LOD and the LOQ is using signal-to-noise ratios (S/N), commonly 3:1 for LOD and 10:1 for LOQ. An appropriate number of samples must be analyzed to fully validate the method performance at the limit. Limit of quantitation (LOQ) Lowest concentration of an analyte in a sample that can be quantified with acceptable precision and accuracy under the stated operational conditions of the method Linearity Ability of a method to provide results that are directly proportional to analyte concentration within a given range Guidelines specify that a minimum of five concentration levels be used to determine the range and linearity, along with certain minimum specified ranges depending on the type of method. The range is normally expressed in the same units as the test results obtained by the method (for example, nanograms per millilitre). Data to be reported generally include the equation for the calibration curve line, the coefficient of determination (r 2), residuals, and the curve itself. Range Interval between the upper and lower concentrations of an analyte that have been demonstrated to be determined with acceptable precision, accuracy, and linearity using the method Robustness Measure of a methods capacity to obtain comparable and acceptable results when perturbed by small but deliberate variations in procedural parameters It provides an indication of the methods suitability and reliability during normal use. During a robustness study, method parameters (such as eluent composition, gradient, and detector settings) are intentionally varied to study the effects on analytical results. Common chromatography parameters used to measure and document robustness include critical peak pair resolution (R s), plate number (N) or peak width in gradient elution, retention time (t R), tailing factor (T F), peak area (and height) and concentration. Robustness studies are expected to be done during method development. Table 7 gives an overview of the performance characteristic tests that have to be performed on different types of analytical procedures.9 Figure 6: Performance Characteristic tests performed on different Types of Analytical Procedures The performance characteristics are evaluated by comparing the results to the specifications defined at the development stage. An analytical method is considered to be validated when it meets the specifications defined at the development stage. Once an analytical method has been made a formal part of the manufacturing process, it is extremely difficult to remove it. In the event of changes in the drug substance, the composition of the finished product and in the analytical procedure, revalidation may be necessary.5,7,9 3.5 Validation Documentation Every validation step needs to be documented to be able to provide written evidence to the regulatory authorities that a specific method is fit for its purpose. Documentation associated with method validation are validation protocols, standard operating procedures (SOPs), specifications and validation reports. Downstream processing in biopharmaceutical manufacturing involves many analytical methods which help to ensure quality, safety and efficacy of the final drug product. Development, validation and control of a robust analytical method is a lengthy and difficult task. However, without written evidence that an analytical method is fit for its intended use the company will not obtain a marketing authorisation. Over time, many guidelines and pharmacopeial monographs have been issued and a lot of revision activity has happened especially following the Stimuli to Revision paper published in 2013. Even though, no comprehensive guideline or monograph incorporating the modern lifecycle approach has been issued yet. Although proper development of robust and effective analytical methods is more time-consuming and expensive, it has many advantages. It leads to more efficient validation, variability is reduced and controlled and analytical method-related out-of-specification results and failure investigation are minimised. Additionally, changing method parameters within the design space facilitates continual improvement as it does not require regulatory re-approval. Validation is a team effort. Members of the CFT need to be properly trained. Their first and most demanding task is the preparation of a protocol which defines the scope of the validation project and provides all details necessary for a successful validation. It also defines, depending on the type of the analytical procedure, which performance characteristics need to be tested. The use of well characterised reference materials with known purity is important. Analytical method validation is considered to be complete when all acceptance criteria are met and a validation report has been written.       Bibliography References 1 Choudhary, A. (2009). Validation in Pharmaceutical Manufacturing. Pharmaceutical Guideline. [Accessed on 1 March 2017]. Available on Internet: http://www.pharmaguideline.com/2010/12/validation.html 2 International Conference on Harmonization (2009). Harmonised Tripartite Guideline: ICH Q8(R2) Pharmaceutical Development. [Accessed on 1 March 2017]. Available on Internet: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf 3 Stockbridge, P. (2008). Biopharmaceutical Fill and Finish: Technical and Operating Challenges for the Latest Formulations and Devices. BioProcess International. [Accessed on 7 March 2017]. Available on Internet: http://www.bioprocessintl.com/2008/biopharmaceutical-quality-assurance-184041/ 4 Nandhakumar, L.; Dharmamoorthy, G.; Rameshkumar, S.; Chandrasekaran, S. (2011). An Overview of Pharmaceutical Validation: Quality Assurance View Point. IJRPC, 1(4). [Accessed on 1 March 2017]. Available on Internet: http://www.caidat.org/m4atomp3/2561456335400862.pdf 5 Lutz, H. (2005). Introduction to Validation of Biopharmaceuticals. BioPharm International. [Accessed on 1 March 2017]. Available on Internet: http://www.biopharminternational.com/introduction-validation-biopharmaceuticals 6 USP Validation and Verification Expert Panel (2013). Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. Stimuli to the Revision Process Article. [Accessed on 1 March 2017]. Available on Internet: https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/lifecycle_pdf.pdf 7 Shabir, G. A. (2004). Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry. IVT Network: Analytical Method Validation, pp. 4-14. [Accessed on 2 March 2017]. Available on Internet: http://www.ivtnetwork.com/sites/default/files/Analytical%20Method%20Validation.pdf 8 U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Parts 211.165(e), 211.194(a) and 211.100(a). [Accessed on 2 March 2017]. Available on Internet: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=211 9 International Conference on Harmonization (2005). Harmonised Tripartite Guideline: ICH Q2(R1) Validation of Analytical Procedures, Text and Methodology. [Accessed on 1 March 2017]. Available on Internet: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html 10 McDowall, R. D. (2014). GLP and GMP Approaches to Method Validation Going the same Way?. Spectroscopy, 29(4). [Accessed on 1 March 2017]. Available on Internet: http://www.spectroscopyonline.com/glp-and-gmp-approaches-method-validation-going-same-way 11 U.S. Pharmacopeial Convention (2016). General Chapter Prospectus: The Analytical Procedure Lifecycle. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/notices/1220-analytical-procedure-lifecycle 12 U.S. Pharmacopeial Convention (2014). New USP requirements for Analytical Method Validation. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/pharmacopeial-forum 13 ECA Academy (2017). Revised USP Chapter Validation of Compendial Methods approved. [Accessed on 2 March 2017]. Available on Internet: http://www.gmp-compliance.org/gmp-news/revised-usp-chapter-1225-validation-of-compendial-methods-approved 14 Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/flyers/Public/Recent_regulatory_updates_and_trends_in_analytical_method_validation.pdf Illustrations Figure 1: Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/fl

Interview With a Human Resources Manger Essay -- Interview Essay

I have taken an interview of the Human Resources Manager Mr. John Smith of a respected University. I asked him to come for a coffee at Starbucks coffee shop. He did not refuse me and came at time. First, I shared my course content and whatever I knew about course and career. I started with explaining many things regarding human resource management, as he is the most competent Human Resources Manager in my eyes. I started by describing about what our College is teaching about Human Resource Management. A. Thesis Statement Reflection, research, and mentorship help to embrace truth for our benefit, which helps to become individuals that are more authentic. An effective leader knows his or her own strengths and weaknesses, passions and obligations, and is always learning better to manage his or her own emotions, faults, and challenges. II. Discussion With that interview, I have learnt a lot of leadership styles and motivational theories, which I studied in my University lectures from Mr. John. This paper is the reflection of what I learnt from him. A. Effective Leadership The leadership is a result of a combination of traits, with special emphasis on the personal qualities of the leader, which he should possess certain personality traits that would be special facilitators in leadership performance. This theory shows that leaders are born as such, there is no likelihood of 'making' them later with personal development techniques. The vision of leadership that leaders are born made, and not learn to be leaders is still considered but not popular among researchers (Avolio et al, 2013). 1. Traits The trait theory prevailed until the forties, passing these characteristics to be studied within a universalistic perspective.... ...ted Bedford, C., & Gehlert, K. M. (2013). Situational Supervision: Applying Situational Leadership to Clinical Supervision. The Clinical Supervisor, 32(1), 56-69. Peus, C., Braun, S., & Frey, D. (2013). Situation-based measurement of the full range of leadership model—Development and validation of a situational judgment test. The Leadership Quarterly, 24(5), 777-795. Barrick, M. R., Mount, M. K., & Li, N. (2013). The theory of purposeful work behavior: The role of personality, higher-order goals, and job characteristics. Academy of Management Review, 38(1), 132-153. Avolio, B. J., & Yammarino, F. J. (Eds.). (2013). Transformational and Charismatic Leadership:: the Road Ahead. Emerald Group Publishing. Sternberg, R. J. (2013). Perspectives: Leadership Styles for Academic Administrators: What Works When?. Change: The Magazine of Higher Learning, 45(5), 24-27.