Product quality and compliance in the pharmaceutical industry

This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.

“PROSPERING BECAUSE THAT’S ITS HISTORY”: BLACK RESILIENCE AND HONORS DEVELOPMENT IN HIGHER EDUCATION: MORGAN STATE UNIVERSITY AND THE STATE OF MARYLAND, 1867-1988

This study explores the origins and development of honors education at a Historically Black College and University (HBCU), Morgan State University, within the context of the Maryland higher education system. During the last decades, public and private institutions have invested in honors experiences for their high-ability students. These programs have become recruitment magnets while also raising institutional academic profiles, justifying additional campus resources. The history of higher education reveals simultaneous narratives such as the tension of post-desegregated Black colleges facing uncertain futures; and the progress of the rise and popularity of collegiate honors programs. Both accounts contribute to tracing seemingly parallel histories in higher education that speaks to the development of honors education at HBCUs. While the extant literature on honors development at Historically White Institutions (HWIs) of higher education has gradually emerged, our understanding of activity at HBCUs is spotty at best. One connection of these two phenomena is the development of honors programs at HBCUs. Using Morgan State University, I examine the role and purpose of honors education at a public HBCU through archival materials and oral histories. Major unexpected findings that constructed this historical narrative beyond its original scope were the impact of the 1935/6 Murray v Pearson, the first higher education desegregation case. Other emerging themes were Morgan’s decades-long efforts to resist state control of its governance, Maryland’s misuse of Morrill Act funds, and the border state’s resistance to desegregation. Also, the broader histories of Black education, racism, and Black citizenship from Dred Scott and Plessy, the 1863 Emancipation Proclamation to Brown, inform this study. As themes are threaded together, Critical Race Theory provides the framework for understanding the emerging themes. In the immediate wake of the post-desegregation era, HBCUs had to address future challenges such as purpose and mission. Competing with HWIs for high-achieving Black students was one of the unanticipated consequences of the Brown decision. Often marginalized from higher education research literature, this study will broaden the research repository of honors education by documenting HBCU contributions despite a challenging landscape.

Measuring quality : how does this improve construction performance?

The paper charts the history and development of the Hong Kong Housing Department (HKHD) Performance Assessment Scoring System (PASS) from 1990 to the present day and examines its effect on facilitating change to the quality of construction work of building contractors engaged in the production of public sector housing projects Hong Kong. The paper builds partly on empirical research carried out by the author as part of a doctoral thesis from 2000 to 2005, on experiential knowledge and also on some relevant case studies. The outcomes from this earlier research and validation of PASS based on results derived from the system since the research was originally undertaken are of benefit to practitioners and academics working and studying in the areas of performance assessment and organisational culture and change. The conclusions presented in the paper further underpin the connection established in previous research between strong organisational culture and project and corporate success. Organisational culture was measured using a survey instrument originally developed by Denison and Neale (1994), adapted for the environment of the study, and corporate success was measured by the PASS system mentioned above. The major results of the original study indicate that there is significant linkage between strong organisational cultures and business success and the detailed findings were that, (1) strong organisational culture was positively associated a high level of company effectiveness, (2) a high level of company effectiveness was positively associated with the cultural traits of ‘consistency’, ‘adaptability’ and ‘mission’, and (3) a high level of company effectiveness was positively associated with the combined cultural traits represented by the dimensions of ‘external focus’ and ‘stable culture’. Several opportunities to take forward this research have been identified, including extending the study to other countries and also longitudinally re-evaluating some of the original case studies to ascertain how organisational cultures have changed or further developed in relation to the changing construction climate in Hong Kong.

Valuing the impact of the teacher librarian from an evidence base

Evidence-based practice as it applies to the Library and Information (LIS) sector and in particular teacher librarians is the focus of this research investigation. The context for this research is Australian school libraries and teacher librarians. This is a research in progress and the report here will include some very early findings and lessons learned from the initial pilot study. The contributions of this research will be in developing a framework for the library and information sector with a particular application for teacher librarians. Providing meaningful evidence of work practices that demonstrate contributions to the schools goals and mission statements in conjunction with contributions to student academic, social and cultural achievements are crucial for the future of the teacher librarian.

Implementing an employee performance management system in a nonprofit organization

Nonprofit organizations are not exempt from the imperatives of employee attraction, retention, and motivation. As competition for staff, donors, and funding increases, the need to manage employee performance will continue to be a critical human resource management issue. This article outlines a study of the introduction of a performance management system in an Australian nonprofit organization and analyzes its design and implementation. It explores how performance management can be introduced and used effectively within a nonprofit environment to benefit staff and the organization. However, the use of performance management is not without its challenges, and the research also identified initial employee resistance and a resulting initial spike in labor turnover. However, findings indicate that if nonprofit organizations are willing to undertake consultation with staff and ensure that the organization's specific context, values, and mission are reflected in the performance management system, it can be a useful tool for managers and a direct benefit to employees.

Aircraft emission reduction through multi-disciplinary flight path optimisation

There is worldwide interest in reducing aircraft emissions. The difficulty of reducing emissions including water vapour, carbon dioxide (CO2) and oxides of nitrogen (NOx) is mainly due from the fact that a commercial aircraft is usually designed for a particular optimal cruise altitude but may be requested or required to operate and deviate at different altitude and speeds to archive a desired or commanded flight plan, resulting in increased emissions. This is a multi- disciplinary problem with multiple trade-offs such as optimising engine efficiency, minimising fuel burnt, minimise emissions while maintaining aircraft separation and air safety. This project presents the coupling of an advanced optimisation technique with mathematical models and algorithms for aircraft emission reduction through flight optimisation. Numerical results show that the method is able to capture a set of useful trade-offs between aircraft range and NOx, and mission fuel consumption and NOx. In addition, alternative cruise operating conditions including Mach and altitude that produce minimum NOx and CO2 (minimum mission fuel weight) are suggested.

The impact of organisational culture on the project selection process : The case of public infrastructure project in Indonesia

Project selection is a complex decision-making process as it involves multiple objectives, constraints and stakeholders. Understanding the organisation, in particular organisational culture, is an essential stage in improving decision-making process. The influences of organisational culture on decision-making can be seen in the way people work as a team, act and cooperate in their teamwork to achieve the set goals, and also in how people think, prioritize and decide. This paper aims to give evidence of the impact of organisational culture on the decision-making process in project selection, in the Indonesian context. Data was collected from a questionnaire survey developed based on the existing models of organisational culture (Denison 1990, Hofstede 2001, and Glaser et al 1987). Four main cultural traits (involvement, consistency, mission and power-distance) were selected and employed to examine the influence of organisational culture on the effectiveness of decision-making in the current Indonesian project selection processes. The results reveal that there are differences in organisational cultures for two organisations in three provinces. It also suggests that organisational culture (particularly the traits of ‘involvement’, ‘consistency’ and ‘mission’) contribute to the effectiveness of decision-making in the selected cases.

FPGA implementation of an evolutionary algorithm for autonomous unmanned aerial vehicle on-board path planning

In this paper, a hardware-based path planning architecture for unmanned aerial vehicle (UAV) adaptation is proposed. The architecture aims to provide UAVs with higher autonomy using an application specific evolutionary algorithm (EA) implemented entirely on a field programmable gate array (FPGA) chip. The physical attributes of an FPGA chip, being compact in size and low in power consumption, compliments it to be an ideal platform for UAV applications. The design, which is implemented entirely in hardware, consists of EA modules, population storage resources, and three-dimensional terrain information necessary to the path planning process, subject to constraints accounted for separately via UAV, environment and mission profiles. The architecture has been successfully synthesised for a target Xilinx Virtex-4 FPGA platform with 32% logic slices utilisation. Results obtained from case studies for a small UAV helicopter with environment derived from LIDAR (Light Detection and Ranging) data verify the effectiveness of the proposed FPGA-based path planner, and demonstrate convergence at rates above the typical 10 Hz update frequency of an autopilot system.

Get Into Vocational Education (GIVE) Gladstone Pilot Project : Final Report to Rio Tinto Alcan Community Fund

This report describes the Get Into Vocational Education (GIVE) pilot project run at Gladstone Central State School from September to December 2010. The report describes the aims, budget, and timeline of the project and its findings in relation to each of the three major objectives of the project, namely (a) build awareness of, interest in, and familiarity with trades as a future vocation and opportunity for advancement; (b) enhance literacy, numeracy and science knowledge and performance; and (c) provide motivation and engagement to stay on at school and build towards a productive future. The clear findings of the GIVE Gladstone Year 4 pilot project are that, for students at risk in terms of school attendance, engagement and learning: (1) awareness of trades, literacy, mathematics and science knowledge, and motivation and engagement all improve and, in most cases, dramatically improve, in the GIVE structure; (2) this improvement involves transfer to situations and concepts not directly addressed in the project; and (3) the crucial factor in the GIVE structure that gives the improvement is the integration of classroom work with trades experiences and not the classroom and trades experiences themselves (although it is better if these are good).

Get Into Vocational Education (GIVE) Rockhampton Region Pilot Project : Final Report to The John Villiers Trust

This report describes the Get Into Vocational Education (GIVE) pilot project run in the Rockhampton Region at two schools in 2011. The report includes a description of the project, including its aims, budget, and timeline; and the findings in relation to each of the three major objectives of the project, namely (a) build awareness of, interest in, and familiarity with, trades as a future vocation and opportunity for advancement; (b) enhance literacy, numeracy and science knowledge and performance; and (c) provide motivation and engagement to stay on at school and build towards a productive future. The clear findings of the GIVE Rockhampton Region pilot project are that, for students at risk in terms of school attendance, engagement and learning: (1) awareness of trade practices in horticulture, hospitality, retail, and design and engineering, literacy, mathematics and science knowledge, and motivation and engagement all improve and, in most cases, dramatically improve, in the GIVE structure; and (2) the crucial factor in the GIVE structure that gives the improvement is the integration of classroom work with trades experiences and not the classroom and trades experiences themselves (although it is better if these are good).

Multiuser virtual safety training system for tower crane dismantlement

Tower crane dismantling is one of the most dangerous activities in the construction industry. Tower crane erection and dismantlement causes 10–12% of the fatalities of all crane accidents. The nature of the task is such that off-the-job training is not practicable, and the knowledge and expertise needed has to be gained on the job. However, virtual trainers such as Microsoft Flight Simulator for airplane pilots and mission rehearsal exercise (MRE) for army personnel have been developed and are known to provide a highly successful means of overcoming the risks involved in such on-the-job learning and clearly have potential in construction situations. This paper describes the newly developed multiuser virtual safety training system (MVSTS) aimed at providing a similar learning environment for those involved in tower crane dismantlement. The proposed training system is developed by modifying an existing game engine. Within the close-to-reality virtual environment, trainees can participate in a virtual dismantling process. During the process, they learn the correct dismantling procedure and working location and to cooperate with other trainees by virtually dismantling the crane. The system allows the trainees to experience the complete procedure in a risk-free environment. A case study is provided to demonstrate how the system works and its practical application. The proposed system was evaluated by interviews with 30 construction experts with different backgrounds, divided into three groups according to their experience and trained by the traditional and virtual methods, respectively. The results indicate that the trainees of the proposed system generally learned better than those using the traditional method. The ratings also indicate that the system generally has great potential as a training platform.

Models of social media adoption in emergency management organisations

Recent natural disasters such as the Haitian earthquake 2011, the South East Queensland floods 2011, the Japanese earthquake and tsunami 2011 and Hurricane Sandy in the United States of America in 2012, have seen social media platforms changing the face of emergency management communications, not only in times of crisis and also during business-as-usual operations. With social media being such an important and powerful communication tool, especially for emergency management organisations, the question arises as to whether the use of social media in these organisations emerged by considered strategic design or more as a reactive response to a new and popular communication channel. This paper provides insight into how the social media function has been positioned, staffed and managed in organisations throughout the world, with a particular focus on how these factors influence the style of communication used on social media platforms. This study has identified that the social media function falls on a continuum between two polarised models, namely the authoritative one-way communication approach and the more interactive approach that seeks to network and engage with the community through multi-way communication. Factors such the size of the organisation; dedicated resourcing of the social media function; organisational culture and mission statement; the presence of a social media champion within the organisation; management style and knowledge about social media play a key role in determining where on the continuum organisations sit in relation to their social media capability. This review, together with a forthcoming survey of Australian emergency management organisations and local governments, will fill a gap in the current body of knowledge about the evolution, positioning and usage of social media in organisations working in the emergency management field in Australia. These findings will be fed back to Industry for potential inclusion in future strategies and practices.

Advances in gyro-stabilisation of vessel roll motion

The use of gyro-dynamic forces to counteract the wave-induced roll motion of marine vessels in a seaway was proposed over 100 years ago. These early systems showed a remarkable performance, reporting roll reductions of up to 95% in some sailing conditions. Despite this success, further developments were not pursued since the systems were unable to provide acceptable performance over an extended envelope of sailing and environmental conditions, and the invention of fin roll stabilisers provided a satisfactory alternative. This has been attributed to simplistic controls, heavy drive systems, and large structural mass required to withstand the loads given the low strength materials available at the time. Today, advances in material strength, bearings, motor technology and mechanical design methods, together with powerful signal processing algorithms, has resulted in a revitalized interest in gyro-stabilisers for ships. Advanced control systems have enabled optimisation of restoring torques across a range of wave environments and sailing conditions through adaptive control system design. All of these improvements have resulted in increased spinning speed, lower mass, and dramatically increased stabilising performance. This brief paper provides an overview of recent developments in the design and control of gyro-stabilisers of ship roll motion. In particular, the novel Halcyon Gyro-Stabilisers are introduced, and their performance is illustrated based on a simulation case study for a naval patrol vessel. Given the growing national and global interest in small combatants and patrol vessels, modem gyro-stabilisers may offer a significant technological contribution to the age old problem of comfort and mission operability on small ships, especially at loiter speeds.

Usulan kerangka kebijakan penggunaan media sosial untuk perpustakaan perguruan tinggi

This study provides proposed core elements of social media policy that specifically designed for academic libraries.Evaluation of social media policies from five organisations and a review of the literature were used for data collection.There are 15 proposed core elements recommended: policy objectives; policy definition; scope of the policy;university’s vision and mission; policy users; disclaimer; confidentiality; copyright; privacy; workflow; publicinformation; the use of professional language; the accuracy of the information; rule for links; and university andlibrary’s voices. The results of this study provide important aspects in the development of social media policy. Theproposed core elements of the social media policy discussed in this paper is specifically designed for the academiclibraries, but can also be used for other library types. Kajian ini memuat usulan kerangka kebijakan penggunaan media sosial dari elemen-elemen inti yang disusun khusus untuk perpustakaan perguruan tinggi. Evaluasi kebijakan penggunaan media sosial dari lima organisasi dan kajian literatur digunakan untuk pengumpulan data. Ada 15 elemen inti kebijakan yang diusulkan, yaitu: tujuan kebijakan; definisi kebijakan; lingkup kebijakan; visi dan misi universitas; sasaran pengguna kebijakan; disclaimer; kerahasiaan; hak cipta; privasi; alur kerja; informasi publik; penggunaan bahasa professional; keakuratan informasi; kaidah tautan; serta suara universitas dan perpustakaan. Hasil kajian ini menyediakan aspek penting dalam pengembangan kebijakan penggunaan media sosial. Usulan elemen inti kebijakan yang diusulkan dalam kajian ini secara khusus dirancang untuk perpustakaan perguruan tinggi, tetapi dapat juga digunakan untuk perpustakaan jenis lainnya.

LunaRoo: A Proposal for the Google Lunar XPrize Payload Opportunity with the Part Time Scientists team

This proposal describes the innovative and competitive lunar payload solution developed at the Queensland University of Technology (QUT)–the LunaRoo: a hopping robot designed to exploit the Moon's lower gravity to leap up to 20m above the surface. It is compact enough to fit within a 10cm cube, whilst providing unique observation and mission capabilities by creating imagery during the hop. This first section is deliberately kept short and concise for web submission; additional information can be found in the second chapter.