They have been the Federation's staunchest allies, and its fiercest adversaries. Cunning, ruthless, driven by an instinct for violence and defined by a complex code of honor, they must push ever outward in order to survive, defying the icy ravages of space with the fire of their hearts. They are the Klingons, and if you think you already know all there is to learn about them...think again. From its highest echelons of power to the shocking depths of its lowest castes, from its savagely aggressive military to its humble farmers, from political machinations of galactic import to personal demons and family strife, the Klingon Empire is revealed as never before when the captain and crew of the I.K.S. Gorkon finally return to their homeworld of Qo'noS in a sweeping tale of intrigue, love, betrayal, and honor.

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ● End of chapter templates, checklists, and LCS guidance to help you follow the required standards ● Electronic versions of each tool so users can use them outside of the text ● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

The Byronic Hero in Film, Fiction, and Television bridges nineteenth- and twentieth-century studies in pursuit of an ambitious, antisocial, arrogant, and aggressively individualistic mode of hero from his inception in Byron’s Manfred, Childe Harold, and Cain, through his incarnations as the protagonists of Westerns, action films, space odysseys, vampire novels, neo-Gothic comics, and sci-fi television. Such a hero exhibits supernatural abilities, adherence to a personal moral code, ineptitude at human interaction (muddled even further by self-absorbed egotism), and an ingrained defiance of oppressive authority. He is typically an outlaw, most certainly an outcast or outsider, and more often than not, he is a he. Given his superhuman status, this hero offers no potential for sympathetic identification from his audience. At best, he provides an outlet for vicarious expressions of power and independence. While audiences may not seek to emulate the Byronic hero, Stein notes that he desires to emulate them; recent texts plot to “rehumanize” the hero or to voice through him approbation and admiration of ordinary human values and experiences. Tracing the influence of Lord Byron’s Manfred as outcast hero on a pantheon of his contemporary progenies—including characters from Pale Rider, Unforgiven, The Terminator, Alien, The Crow, Sandman, Star Trek: The Next Generation,and Angel—Atara Stein tempers her academic acumen with the insights of a devoted aficionado in this first comprehensive study of the Romantic hero type and his modern kindred. Atara Stein was a professor of English at California State University, Fullerton. Her articles on the development of the Byronic hero have appeared in Popular Culture Review, Romantic Circles Praxis Series, Genders, and Philological Quarterly.

Revisit some of the best adventures of Captain Picard in this extra-long collection! Featuring stories from across multiple Star Trek comic publishers, this issue is perfect for any fan wanting to learn more about the celebrated Starfleet officer.

All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.

Turbulent development projects experience daily changes in requirements. Keeping your testing efforts on track while reacting to rapidly shifting priorities, technologies, and user needs can often feel nearly insurmountable. Charting the Course: Coming up with Great Test Ideas Just in Time equips you with effective techniques to implement software testing in chaotic environments. You will learn practical, dynamic test planning and scheduling, along with exploratory, scripted, automated, and performance testing, which can be successfully and systematically implemented in various contexts. This book focuses on generating a wide variety of relevant and powerful testing ideas that can be applied to real projects using Agile, Iterative, Waterfall, or Hybrid development environments. Readers will explore: • The foundation for thousands of potentially relevant testing ideas • Test ideas oriented toward software capabilities, based on expected functionality • Test ideas based on usage scenarios, addressing user needs • Test ideas based on failure modes, challenging software design and environment dependencies • Numerous non-functional software attributes that pose a risk to software value • Creative testing ideas that uncover significant bugs through lateral thinking • Additional sources of important test ideas, including Business Rules, Combinations, States, Data, Environments, Unit Tests, Taxonomies, Test Oracles, Creative Ideas, Path Test Ideas, Boundary Test Ideas, Automation Test Ideas, and Regression Test Ideas • Formulating charters to guide and direct software testing efforts Enjoy Charting the Course and learn how to achieve exceptional testing outcomes even in the most challenging and chaotic contexts.

The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.