Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Download or read book DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon M. Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

Download or read book Compliance by Design written by Chong Ee and published by IT Governance Publishing. This book was released on 2011-09-27 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Compliance by Design, Chong Ee will show you how your organisation can benefit from becoming compliant with the relevant national and international standards. You will discover how integrating controls into your processes will improve your security, increase your productivity, save you time and money, and increase your profits.

Download or read book Standards for Internal Control in the Federal Government written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.

Download or read book Designing Controls for the Process Industries written by Wayne Seames and published by CRC Press. This book was released on 2017-09-05 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offering a modern, process-oriented approach emphasizing process control scheme development instead of extended coverage of LaPlace space descriptions of process dynamics, this text focuses on aspects that are most important for process engineering in the 21st century. Instead of starting with the controller, the book starts with the process and moves on to how basic regulatory control schemes can be designed to achieve the process’ objectives while maintaining stable operations. In addition to continuous control concepts, process and control system dynamics are embedded into the text with each new concept presented. The book also includes sections on batch and semi-batch processes and safety automation within each concept area. It discusses the four most common process control loops—feedback, feedforward, ratio, and cascade—and discusses application of these techniques for process control schemes for the most common types of unit operations. It also discusses more advanced and less commonly used regulatory control options such as override, allocation, and split range controllers, includes an introduction to higher level automation functions, and provides guidance for ways to increase the overall safety, stability, and efficiency for many process applications. It introduces the theory behind the most common types of controllers used in the process industries and also provides various additional plant automation-related subjects.

Download or read book Control System Design Guide written by George Ellis and published by Butterworth-Heinemann. This book was released on 2012-05-15 with total page 521 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title will help engineers to apply control theory to practical systems using their PC. It provides an intuitive approach to controls, avoiding unecessary math and emphasising key concepts with control system models

Download or read book Operational Risk Management written by Jasmijn Bol and published by Business Expert Press. This book was released on 2021-05-15 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: To remain viable, let alone competitive, organizations must manage risks. In this book, we explore the concept of operational risk as well as the mechanisms used to diminish the impact and occurrence of risks: the organizational control system. Since the scope and scale of operational risks are unique to each organization, our objective is to explain the theory behind why and how managers respond to the unique combination of threats that challenge their organization. We emphasize employee management and the complexities surrounding the design of management controls, incentive systems in particular, because risks related to employee actions are faced by virtually every organization. Overall, we provide empirically grounded insights into the process of diagnosing operational risks as well as designing, implementing and maintaining a control system that properly manages those risks.

Download or read book Internal Controls written by Lynford Graham and published by John Wiley & Sons. This book was released on 2007-09-10 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new age of philanthropy, donors expect charities to be models of accountability and transparency...Internal controls: Guidance for Private, Government, and Nonprofit Entities is a must read for CEOs and CFOs who want to gain a clear understanding of cost-effective ways to implement the controls necessary to protect their organizations." - Elizabeth Myatt, Chief Executive Officer, World Lung Foundation "If you were looking for the silver bullet to understand and audit internal controls, you just found it. This book will prove invaluable in planning the audit internal controls, you just found it. This book will prove invaluable in planning the audit because it specifically covers COSO and the new AICPA risk assessment auditing standards. " - George I. Victor, CPA, Partner in Charge of Quality Control, Holtz Rubenstein Reminick LLP "Author Lyn Graham gives practical, easy-to-understand guidance for documenting internal controls. I recommend this book for both my clients and our staff. It is very useful for auditors and clients alike." - David E. Adams, CPA, Partner, Geffen Mesher & Company "This book is an essential guide...and provides very practical advice about what to do(and what not to do) in making an investment in internal controls. The author's expensive experience as an audit firm partner and standard-setter are evident in the details provided. I also recommend this book to teaches of auditing and systems, as it provides a useful background to...how internal controls really should work in today's business environment." - Jean C. Bedard, CPA, PhD, Timothy B. Harbert Professor of Accountancy, Bentley College

Download or read book Greenhouse Design and Control written by Pedro Ponce and published by CRC Press. This book was released on 2014-09-11 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals with different types of greenhouses, materials, structures, advanced control techniques and tendencies that are needed for designing and controlling an advanced greenhouse. The control system is presented as an integral system which covers the explanation of basic and advanced concepts for a real time controller. Also, structural analysis is introduced, whereby mechanical design is regarded as a key factor. The book incorporates simulations and experimental results, and utilizes LabVIEW and ADAMS software. Finally, it provides a perspective on the present state and future of greenhouses globally.

Download or read book Aircraft Control and Simulation written by Brian L. Stevens and published by John Wiley & Sons. This book was released on 2015-10-02 with total page 768 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get a complete understanding of aircraft control and simulation Aircraft Control and Simulation: Dynamics, Controls Design, and Autonomous Systems, Third Edition is a comprehensive guide to aircraft control and simulation. This updated text covers flight control systems, flight dynamics, aircraft modeling, and flight simulation from both classical design and modern perspectives, as well as two new chapters on the modeling, simulation, and adaptive control of unmanned aerial vehicles. With detailed examples, including relevant MATLAB calculations and FORTRAN codes, this approachable yet detailed reference also provides access to supplementary materials, including chapter problems and an instructor's solution manual. Aircraft control, as a subject area, combines an understanding of aerodynamics with knowledge of the physical systems of an aircraft. The ability to analyze the performance of an aircraft both in the real world and in computer-simulated flight is essential to maintaining proper control and function of the aircraft. Keeping up with the skills necessary to perform this analysis is critical for you to thrive in the aircraft control field. Explore a steadily progressing list of topics, including equations of motion and aerodynamics, classical controls, and more advanced control methods Consider detailed control design examples using computer numerical tools and simulation examples Understand control design methods as they are applied to aircraft nonlinear math models Access updated content about unmanned aircraft (UAVs) Aircraft Control and Simulation: Dynamics, Controls Design, and Autonomous Systems, Third Edition is an essential reference for engineers and designers involved in the development of aircraft and aerospace systems and computer-based flight simulations, as well as upper-level undergraduate and graduate students studying mechanical and aerospace engineering.

Download or read book Designing and Using ActiveX Controls written by Tom Armstrong and published by Wiley. This book was released on 1997-01-13 with total page 629 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here is everything you need to know about creating and using ActiveX controls, from the perspective of a professional programmer. It tells what tools to use, what Microsoft standards to follow, and how to design specifically for the Web. The CD-ROM contains all the source code in the book, as well as more than 30 invaluable pre-built ActiveX controls to integrate into your programs.

Download or read book Feedback Control Theory written by John C. Doyle and published by Courier Corporation. This book was released on 2013-04-09 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: An excellent introduction to feedback control system design, this book offers a theoretical approach that captures the essential issues and can be applied to a wide range of practical problems. Its explorations of recent developments in the field emphasize the relationship of new procedures to classical control theory, with a focus on single input and output systems that keeps concepts accessible to students with limited backgrounds. The text is geared toward a single-semester senior course or a graduate-level class for students of electrical engineering. The opening chapters constitute a basic treatment of feedback design. Topics include a detailed formulation of the control design program, the fundamental issue of performance/stability robustness tradeoff, and the graphical design technique of loopshaping. Subsequent chapters extend the discussion of the loopshaping technique and connect it with notions of optimality. Concluding chapters examine controller design via optimization, offering a mathematical approach that is useful for multivariable systems.

Download or read book Managing Design written by Michael LeFevre and published by John Wiley & Sons. This book was released on 2019-06-05 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers state-of-the-art principles and strategies gleaned from high-profile projects to help readers manage design This guide to managing design process within the commercial design and construction industry addresses a growing pain point in an industry where collaborative approaches to project delivery are outpacing the way professionals work. It synthesizes issues by investigating the “why,” “how,” and “who” of the discipline of managing design, and gives the “what” and “when” to apply the solutions given various project delivery and contracting methods. The book features candid interviews with over 40 industry leaders—architects, engineers, contractors, owners, educators, technology evangelists, and authors—which present a broad look at current issues and offer paths to future collaboration and change. Managing Design: Conversations, Project Controls and Best Practices for Commercial Design and Construction Projects is a self-help book for design and construction that provides aninsider’s look at the mysteries of managing design for yourself, team, firm and future. It tackles client empathy; firm culture; owner leadership; design and budgets; dealing with engineers, consultants, and contractors; contracts; team assembly; and much more. Features eye-opening interviews with 40 industry luminaries Exposes issues and poses solutions to longstanding industry ills Offers a project design controls framework and toolset for immediate application and action Includes best practice tips, process diagrams, and comparative analytical tables to support the text Written in a relatable style, Managing Design: Conversations, Project Controls and Best Practices for Commercial Design and Construction Projects is a welcome resource for owners, contractors, and designers in search of better ways to work together. “Managing Design blends practical advice from the author's five decades in architecture and construction with wisdom from more than three dozen luminaries in the design, delivery, ownership and operation of the built environment. The result is an extraordinary guide to integrating practice across disciplines.” —Bob Fisher, Editor-In-Chief, Design Intelligence “Managing Design peers into the soul of a contentious industry as it grapples with change—a deep dive into the design and construction process in the words of those doing the work. I enjoyed the engineers and contractors’ pleas to be made parties to design process early on. The questions—as interesting as the answers—are both here in this book.” —Richard Korman, Deputy Editor, Engineering News Record “Managing Design hits many of the design and construction industry’s ills head-on with insightful interviews by new and established leaders and real-world tactics on creating better teams, better communications between players, and—most vitally—better project results.” —Rebecca W. E. Edmunds, AIA, Editor, Author and President, r4 llc

Download or read book Aircraft Engine Controls written by Link C. Jaw and published by AIAA Education. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Overview of engine control systems -- Engine modeling and simulation -- Model reduction and dynamic analysis -- Design of set-point controllers -- Design of transient and limit controllers -- Control system integration -- Advanced control concepts -- Engine monitoring and health management -- Integrated control and health monitoring -- Appendix A. Fundamentals of automatic control systems -- Appendix B. Gas turbine engine performance and operability.

Download or read book Digital Control Engineering written by M. Sami Fadali and published by Academic Press. This book was released on 2012-09-06 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: Digital controllers are part of nearly all modern personal, industrial, and transportation systems. Every senior or graduate student of electrical, chemical or mechanical engineering should therefore be familiar with the basic theory of digital controllers. This new text covers the fundamental principles and applications of digital control engineering, with emphasis on engineering design. Fadali and Visioli cover analysis and design of digitally controlled systems and describe applications of digital controls in a wide range of fields. With worked examples and Matlab applications in every chapter and many end-of-chapter assignments, this text provides both theory and practice for those coming to digital control engineering for the first time, whether as a student or practicing engineer. Extensive Use of computational tools: Matlab sections at end of each chapter show how to implement concepts from the chapter Frees the student from the drudgery of mundane calculations and allows him to consider more subtle aspects of control system analysis and design An engineering approach to digital controls: emphasis throughout the book is on design of control systems. Mathematics is used to help explain concepts, but throughout the text discussion is tied to design and implementation. For example coverage of analog controls in chapter 5 is not simply a review, but is used to show how analog control systems map to digital control systems Review of Background Material: contains review material to aid understanding of digital control analysis and design. Examples include discussion of discrete-time systems in time domain and frequency domain (reviewed from linear systems course) and root locus design in s-domain and z-domain (reviewed from feedback control course) Inclusion of Advanced Topics In addition to the basic topics required for a one semester senior/graduate class, the text includes some advanced material to make it suitable for an introductory graduate level class or for two quarters at the senior/graduate level. Examples of optional topics are state-space methods, which may receive brief coverage in a one semester course, and nonlinear discrete-time systems Minimal Mathematics Prerequisites The mathematics background required for understanding most of the book is based on what can be reasonably expected from the average electrical, chemical or mechanical engineering senior. This background includes three semesters of calculus, differential equations and basic linear algebra. Some texts on digital control require more

Download or read book Practical Design and Application of Model Predictive Control written by Nassim Khaled and published by Butterworth-Heinemann. This book was released on 2018-05-04 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Design and Application of Model Predictive Control is a self-learning resource on how to design, tune and deploy an MPC using MATLAB® and Simulink®. This reference is one of the most detailed publications on how to design and tune MPC controllers. Examples presented range from double-Mass spring system, ship heading and speed control, robustness analysis through Monte-Carlo simulations, photovoltaic optimal control, and energy management of power-split and air-handling control. Readers will also learn how to embed the designed MPC controller in a real-time platform such as Arduino®. The selected problems are nonlinear and challenging, and thus serve as an excellent experimental, dynamic system to show the reader the capability of MPC. The step-by-step solutions of the problems are thoroughly documented to allow the reader to easily replicate the results. Furthermore, the MATLAB® and Simulink® codes for the solutions are available for free download. Readers can connect with the authors through the dedicated website which includes additional free resources at www.practicalmpc.com. - Illustrates how to design, tune and deploy MPC for projects in a quick manner - Demonstrates a variety of applications that are solved using MATLAB® and Simulink® - Bridges the gap in providing a number of realistic problems with very hands-on training - Provides MATLAB® and Simulink® code solutions. This includes nonlinear plant models that the reader can use for other projects and research work - Presents application problems with solutions to help reinforce the information learned

Download or read book Organizational Physics The Science of Growing a Business written by Lex Sisney and published by Lulu.com. This book was released on 2013-03-01 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are hidden laws at work in every aspect of your business. Understand them, and you can create extraordinary growth. Ignore them, and you run the risk of becoming another statistic. It's become almost cliche: 8 out of every 10 new ventures fail. Of the ones that succeed, how many truly thrive-for the long run? And of those that thrive, how many continually overcome their growth hurdles ... and ultimately scale, with meaning, purpose, and profitability? The answer, sadly, is not many. Author Lex Sisney is on a mission to change that picture. After more than a decade spent leading and coaching high-growth technology companies, Lex discovered that the companies that thrive do so in accordance with 6 Laws - universal principles that govern the success or failure of every individual, team, and organization.