Medical Device Software Verification, Validation and Compliance by: David A. Vogel
Here s the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.
Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation — to build confidence in your software s safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.
From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer s quality system and is regulated by 21 CFR 820.70(i).
DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book.
Risk-Free Technology: How Small to Medium Businesses Can Stem Huge Losses From Poorly Performing IT Systems by: Charles L. Nault
IT has now reached “utility” status everywhere, at least from an expectation standpoint. Just as the utility of electricity is required to power our lights and equipment, and oil or gas insures our heat in the winter, a firm’s network infrastructure MUST be always in place to maintain its Internet access, computerization, phone system and a host of other mission-critical applications.
Contrary to days passed, companies can no longer function without these. Their customers, employees and vendors expect business networks to be fully functional, expeditious, security protected and accessible around the clock.
This book addresses the implications of failing to insure that all your IT functions are “utility-status,” and tells non-technical executives what needs to be done from a managerial perspective to achieve true utility status, as well as how to pro-actively monitor such functions to make sudden catastrophes a thing of the past. The book will provide case studies of companies who have lost money and business because they failed to heed this message.
Free Agent: The Independent Professional’s Roadmap to Self-Employment Success by: Katy Tynan
There is a seismic shift underway in the employer/employee relationship that is redefining the nature of jobs and careers. Sole proprietors and independent contractors now represent more than 20 percent of the workforce, and that number is expected to reach nearly 50 percent within the next 10 years.
Despite the proliferation of people engaging in freelance and contract work, however, the path to success is not always easy. Free Agent: The Independent Professional’s Roadmap to Self-Employment Success details a pragmatic action plan to help you succeed in this new skills marketplace.
Supplying practical strategies to help you get ahead of the change and become an in-demand resource with a steady stream of income, the book describes how work is changing and what is driving the growth of freelancing. Next, it explains how to get your new independent venture off the ground, how to find your first client, and what you need to know to avoid common pitfalls.
To transition successfully from employee to free agent, you must have a plan to avoid the pitfalls and a support team to give you the expertise on complicated topics such as business structure, contracts, and accounting. This book is your guide to successfully navigating the transition.
Detailing the tools and practices that will enable you to succeed as a free agent, the book includes case studies and interviews with those who have already made the transition. The book concludes by describing how to optimize your new freelance work style to make the most of your time and energy, so you can focus on doing more of what you love.
Leading the High Energy Culture: What the Best CEOs Do to Create an Atmosphere Where Employees Flourish by: David Casullo
Praise for Leading the High-Energy Culture
“If you’re looking for a step-by-step guide on how to become a high-energy leader, you’ve found it here!”
–Tom Croston, Vice President/General Manager of Corporate Shared Services, Gap, Inc.
“Whether its business, sports, or even parenting, successful leaders share one thing in common–high energy! David is right; it can be developed. I find it unique for someone to identify the truly key elements of leadership. David has done this in a way that fosters success in these endeavors as well as those of family, church, and community.”
–Pat Williams, Senior Vice President, Orlando Magic, and author of Leadership Excellence
“Jack Welch identified ‘energy’ as one of the critical characteristics he looked for in effective leaders but never talked about how they develop it. David Casullo’s book provides the road map for how to harness your own energy while energizing those around you. Every leader can increase their effectiveness by implementing the ideas he presents.”
–Patrick M. Wright, William J. Conaty GE Professor of Strategic Human Resources in the ILR School (Industrial and Labor Relations), Cornell University
Leaders and managers today are experiencing an “energy crisis” resulting from the failure to engage and inspire their people. Yet, a handful of leaders have found an endless supply of energy to fuel their organizations. They’re the ones who attract the top talent, the most loyal customers, and the public’s imagination. They’re leaders like Zappos’s Tony Hsieh and the late Steve Jobs, who’ve built cultures energized at every level to innovate, grow, and succeed. Leading the High-Energy Culture: What the Best CEOs Do to Create an Atmosphere Where Employees Flourish is the handbook to powering this kind of workplace with the energy that your workforce already possesses.
A change this big starts at the top. David Casullo, a leadership authority and strategic consultant to businesses large and small, explains the steps for establishing an authentic leadership presence based on your powerful personal truths. Then he shares the secrets for how to communicate your vision in order to create a sense of purpose throughout your organization and beyond, thereby spreading excitement to consumers, investors, and the media. Using his own experience, research, and demonstrated results from the leadership development program that he developed while helping transform Raymour & Flanigan from a small regional company to a billion-dollar furniture retail giant, Casullo outlines the specific steps that let you discover and unlock the latent energy in your team.
Casullo organizes these practices into 10 simple principles, each illustrated and reinforced with firsthand client interviews; real-world examples from businesses such as Ford, FedEx, and GE; and thought-provoking interactive exercises. These principles illuminate the path to creating real employee engagement by giving you an actionable model to:
- Learn what matters to your organization and its people, and align your leadership strategy with these truths
- Communicate clearly, with purpose and passion, to create a resonant message
- Find the leaders in your workforce who give your organization a competitive advantage
Leading the High-Energy Culture uses methods proven to generate results. Beyond the bottom line, however, it will reignite your own commitment and passion by giving you a fresh perspective on how to become an energized leader of a charged-up organization.
ACT Now or Fail! Become an A.C.E. and Lead the Way! by: Christopher Whipple
This book reveals a new concept that all great leaders have utilized but few if any have recognized: By presenting followers with a goal that offers a better future, thereby eliminating fears or major concerns, the leader creates an environment where teamwork naturally thrives, making extremely difficult objectives obtainable. This motivates followers, eliminating the need to utilize critical resources for motivation, and creating an efficiency that no supervision could ever achieve. Once followers start working as a team for the good of the organization, improvements naturally follow, especially in quality. Until now, definitions for quality have been vague and unhelpful at guiding organizations on where to improve. The new definition for quality introduced in this book will assist leaders in any organization to clarify exactly what quality is for that organization, making it possible for each worker to improve their products and services with each action taken. The benefits gained will improve employee and customer satisfaction to previously unheard-of levels. A clarification of how feelings impact overall results will change how future employees and organizations behave, creating an environment that is highly sustainable. Chris Whipple, president of Advanced Corporate Teams, provides training to develop Advanced Corporate Executives (A.C.E.). With over 20 years of management experience and a desire to share best practices, he set out to document a clear process for implementing goals. His research uncovered several missing details that the quality gurus never discovered. This book fills in the gap. He is a graduate of Johnson & Wales University in business management and can be contacted via the Advanced Corporate Teams website: www.advancedcorporateteams.com.