What Would Henry Do?: Essays for the 21st Centuryby: Ken Lizotte
Today on our little planet, we live in bewildering times. We’re essentially faced with this question: what should we be thinking, saying and doing about the challenges bearing down upon our lives? Answers can be hard to come by. Yet we, the community of Thoreau Farm, believe we have to search for them. So we wondered, if Henry David Thoreau were alive today, what would HE think, what HE say, what would HE do?
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.
In the Matter of Michael Vogel by: Drew Yanno
It’s the late summer of 1966 in a small town in upstate New York when the body of eight year old Michael Vogel is found at the bottom of the deep end of the municipal swimming pool four hours after closing.
At first, the townspeople believe the initial reports that it was an accidental drowning, despite the fact that the boy’s body wasn’t discovered when the lifeguards searched the pool earlier in the day after his sister reported him missing. However, when an autopsy reveals an unexpected result, it sets in motion a search for a killer in a town unaccustomed to murder.
The story is told from the perspective of three members of the community: a twelve year old boy with a future he hopes to avoid; a sheriff with a past he wishes to forget; and a forty year old bachelor with a secret he wants desperately to protect. Their stories all come together in a startling and thrilling conclusion that helps to provide a measure of redemption for each of them.
The Expert’s Edge by: Ken Lizotte
You’ve seen them everywhere-on the covers of books and magazines, quoted in newspaper articles, interviewed on the radio and TV. They are the “thoughtleaders,” the high-profile professionals who rise above everyone else in their field to become the go-to experts in all forms of media.
Sound bite needed for what’s happening in real estate? Call Donald Trump. Personal finance questions? Get Suze Orman!
What about you? Who seeks you out for opinions for trends in your specialty? Are you merely an expert in your field or are you the expert? Do you dream of attaining higher levels of business fame and fortune? Is there a way to make that happen?
The answer is Yes-if you’ve got The Expert’s Edge.
An action-ready program of proven success strategies, this easy-to-follow game plan can turn any level of entrepreneur into the must-have expert that prospects and media seek out before all others. You raise your profile, expand demand for your services, and increase your profits. Just follow the “Five Pillars of Thoughtleading”:
1. Publish articles and books
2. Speak regularly to groups and companies
3. Inspire with “fresh” thinking
4. Attract ongoing media attention
5. Leverage the Internet creatively
Used together, these Five Pillars offer an unbeatable strategy for positioning your business as the only one to call. Prospects and clients will think only of you when your service or product is needed. Your competitors are left struggling to catch up.
No matter what you do-entrepreneur, intrapreneur, consultant, manager or specialist-The Expert’s Edgewill elevate you to an enviable status as the go-to-authority in your field.
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.