COMMENTARY Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System Richard L. Friedman Food & Drug Administration‚ Center for Drug Evaluation & Research‚ Division of Manufacturing & Product Quality ABSTRACT: This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000-2004. CGMP deficiencies associated with each contamination event are discussed. The
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Analyze Ford ’s decision to introduce the X-type to broaden Jaguar ’s appeal from niche player to major competitor in the luxury segment. Tata Motors recently introduced the Nano‚ the world ’s least expensive car. The Nano fits Tata ’s strategic goal of building a low-cost car for the Indian market. Give your opinion‚ backed by evidence and sound reasoning‚ on whether Tata can succeed in targeting both the very low end of the auto market as well as the high end. What would they have to do to pull
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Immanuel Kant would have would have certainly believed that Ford acted wrongly by not upgrading the integrity of the Pinto’s fuel system after learning about the danger of explosions in low-speed rear end collisions. Kantian deontology asserts that “nothing can possibly be conceived in the world‚ or even out of it‚ which can be called good‚ without qualification‚ except a good will.” (Kant 1). Although some human qualities are intrinsically valuable‚ or good for their own sake‚ Kant believes that
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Ford KaThe launching team of Ford Ka is facing a changing marketplace for innovative and fresh approaches to segmenting the small car market with attributes that could resonate with the evolving markets. It is recommended that the team should segment their market based on life style and behaviors (i.e. psychographic) to target Freedom Lovers and Attention Seekers then later stage Sensible Classics as below: Stylish and modern urban and suburban individual with acceptable income levels; this group
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movie based on a book is shortened and distorted from its original book to appeal more audiences since a movie appeals more to popular‚ general audiences. It is no exception for Powwow Highway‚ written by David Seals and was later made in movie. One of perspective review article‚ Easin’s on Down the Powwow Highway(s)‚ by Rodney Simard focuses on difference between the film and original novel. It reveals several important points: intensification of Indian stereotype‚ westernized women roles and the
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What was the impact of data quality problems on the companies described in this case study? What management‚ organization‚ and technology factors caused these problems? BT Group had data quality issues within the product inventory and customer billing databases‚ resulting in poor efficiency of the system. The case doesn’t really give the reason that these databases contained inaccurate data. However‚ one can assume that the errors were caused by lack of structure within the organization at data
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gets you there faster. However here’s the thing I found out that the best of America is on blue highways. Around every corner there is something new and different and very interesting. On an interstate the road is flat‚ straight and all of the interesting stuff and places are up on the exit ramp‚ what is fun about that? So here are my responses to how I agree with the author proving that blue highway route 66 represents America. As you know accidents happen a lot on the interstate‚ that takes
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Case Problem 3: Hart Venture Capital 1. Let S = fraction of the Security Systems project funded by HVC M = fraction of the Market Analysis project funded by HVC Max 1‚800‚000S + 1‚600‚000M s.t. 600‚000S + 500‚000M ≤ 800‚000 Year 1 600‚000S + 350‚000M ≤ 700‚000 Year 2 250‚000S + 400‚000M ≤ 500‚000 Year 3 S
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CASE STUDY: BUSINESS FEELS THE CONSEQUENCES OF THE UNINSURED PROBLEM Vanessa Flores November 5‚ 2012 Ashford University Describe the issue based on the topic/content area/change in your own words (2-3 sentences) (the uninsured issue is the case study in this chapter): Uninsured employees choose to stay sick or self-medicate instead of going to see a doctor. This affects the stakeholders because it leads to lower employee morale and productivity due to their health issues that are not being
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for most cases its true. Interstates bypass all the towns‚ cities‚ and highways that people would not notice unless they drove on the highways instead of the interstate. Interstates are long‚ mostly straight‚ flat roads that lead from one place to another. On the interstate‚ semis loom over you like giant beast‚ cascading you and your entire car in a shadow as it rides by. Certain towns‚ shops‚ or cultures can only be found on blue highways‚ roads written in blue on a map‚ these highways can take
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