[N771.Ebook] PDF Download Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory ComplianceFrom CRC Press

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Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory ComplianceFrom CRC Press

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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008


• ICH Guidance Q8, Q9, and Q10 expectations


• FDA cGMPs for the 21st Century Initiative and associated guidance


• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments


• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment


• the indirect developments from FDA/EU/Japan regulators and industry


• the role of QA department, and internal and external suppliers


• the integration of computer systems validation into single overall approach for wider system


• practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system


• managing outsource partners and handling legacy systems


• topical issues uncovered by regulatory authorities including US FDA

• Sales Rank: #1423886 in eBooks
• Published on: 2016-04-19
• Released on: 2016-04-19
• Format: Kindle eBook

Most helpful customer reviews

3 of 3 people found the following review helpful.
Excellent reference for Computer Validation
By Armand Mintanciyan
If you are thinking about a career move into computer validation or are already involved in computer validation this book makes a tremendous reference. I feel this book and the 'GAMP5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems' will be of great value. I have been involved in computer validation since 1994 including lead roles in Consent Decree remediation for computerized systems and I highly recommend this book.

0 of 0 people found the following review helpful.
Validation
By Arlyn R. Sibille
For the serious minded the book has the detail required to understand how to approach the validation of pharmaceutical computer system for laboratory equipment. Based on the Risk Approach.

0 of 0 people found the following review helpful.
This is a useful companion to GAMP 5
By Jeff M. Lewis
This is a useful companion to GAMP 5, and much less expensive. The book is well organized and discusses validation scenarios for a number of different system types.

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[H458.Ebook] Download Instructional Design Frameworks and Intercultural Models, by Patricia A. Young

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The global technological marketplace has brought with it the need to address international and local target audiences. To remain competitive, companies have begun to design ICTs with a focus on generic and specialized users and learners.

Instructional Design Frameworks and Intercultural Models meets the needs of practitioners and researchers by providing frameworks for integrating culture into design. This book offers practical applications for the construction of user interfaces, products, services, and other online environments useful in the development of culture-based designs.

• Sales Rank: #5424721 in Books
• Brand: Brand: Information Science Reference
• Published on: 2008-12-26
• Original language: English
• Number of items: 1
• Dimensions: 10.00" h x .88" w x 7.01" l, 2.05 pounds
• Binding: Hardcover
• 402 pages

Features

• Used Book in Good Condition

About the Author
Patricia A. Young, PhD is an assistant professor in Literacy Education at the University of Maryland, Baltimore County. Dr. Young earned her PhD in Education: Language, Literacy and Culture from the University of California Berkeley. She received her Master of Science degree in Education with an emphasis in Curriculum & Reading from California State University Hayward and a Bachelor of Fine Arts degree in Communication Arts with a specialization in Television Production from New York Institute of Technology. Her current research involves the implementation of the Culture Based Model as a design construct and mapping the model to a variety of interdisciplinary uses. Her research also examines the history of Instructional Design and Technologies made by and for African Americans.

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[Y600.Ebook] Ebook Fundamentals of Enterprise Risk Management: How Top Companies Assess Risk, Manage Exposure, and Seize Opportunity, by John J. Hampton

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Using examples from companies such as Home Depot, Airbus, Boeing, and Nokia, as well as countries including Taiwan and Russia, "Enterprise Risk Management" takes an in-depth look at one of the hottest topics in business today. This title shows readers in charge of monitoring operational exposures in corporations, nonprofit organizations, and government agencies how they can best determine and balance opportunities against the possibilities of loss. Featuring enlightening case studies, interviews, and exercises, this essential book shows readers how they can implement ERM the right way at their organization.

• Sales Rank: #1655536 in Books
• Brand: Brand: AMACOM
• Published on: 2009-08-05
• Original language: English
• Number of items: 1
• Dimensions: 1.20" h x 6.10" w x 9.00" l, 1.35 pounds
• Binding: Hardcover
• 320 pages

Features

• Used Book in Good Condition

Review

"Fundamentals of Enterprise Risk Management offers insights for anyone eager to know more about ERM." --Business Insurance

From the Inside Flap

Anyone could see that offering exotic mortgages to people with lackluster credit histories was a risky proposition. But when the default rate started its inevitable rise, almost no one imagined that large, esteemed financial institutions would actually collapse. What happened? How is it that so many organizations completely failed to understand their risk exposures? Didn’t they have risk management systems in place to reduce those exposures?

 

One thing the financial crisis clearly shows, says the author of Fundamentals of Enterprise Risk Management, is that traditional approaches to risk management are a failure. America’s financial companies kept a narrow, inward focus on limiting the impact of a web of maddeningly complex risk exposures. But the job of enterprise risk management (ERM) is not to centrally control risk, but to accurately identify it—constantly scanning the horizon for changing conditions and monitoring for internal weaknesses—and to share the information widely.

Fundamentals of Enterprise Risk Management offers an expansive yet focused approach that will radically improve your ability to recognize risk and minimize loss, as well as understand the level of risk that’s required to pursue opportunities.

 

Using examples from Home Depot, Boeing, Airbus, Nokia, and many other companies, the book’s insights, strategies, and unique tools help you:

●          Identify your organization’s exposure to a multitude of business, financial, and hazard risks—then visualize risk relationships using innovative new applications, such as Riskonnect®.

●          Recognize hard-to-see internal risk expo­sures, such as weaknesses in your strategy, subcultures that can destroy your goals, and life cycle risks for different lines of business and operating units.

●          Assign “risk owners” for every category of risk—thus eliminating the excessive com­plexity faced by a single risk manager—and align risk accountability with the organiza­tion’s business model.

●          Understand Nassim Taleb’s concept of “black swans”— unpredictable crises that seem to upend risk management stra­te­gies—and learn how seemingly random events are not always unexpected.

●          Examine how companies such as AIG blindly exposed themselves to excessive risk—and how a knowledge warehouse would have clearly illuminated the risk exposures and possibly circumvented the 2008 financial crisis.

●          Focus on the upside of risk and seize oppor­tunities that are attainable only by informed decisions on the acceptance of risk.

 

Comprehensive, refreshingly clear, and packed with the latest insights from the field, Fundamentals of Enterprise Risk Management is essential reading for anyone responsible for monitoring risk exposures, in any setting—corporate, nonprofit, or government.

 

John J. Hampton is the KPMG Professor of Business and Director of Graduate Business programs at St. Peter’s College, and former Executive Director of the Risk and Insurance Management Society (RIMS). He lives in Litchfield, Connecticut.

From the Back Cover

After the devastation experienced by AIG, Bear Stearns, Lehman Brothers, and other financial institutions, the need for effective, comprehensive enterprise risk management (ERM) systems has never been more stark or immediate.

Whether your organization needs to implement an ERM program from scratch or radically improve upon an existing one, Fundamentals of Enterprise Risk Management is the most up-to-date, all-in-one resource for creating a proactive, clearly articulated ERM system. The book shows you how to use a highly innovative and surprisingly easy-to-use visual architecture for accurately identifying your orga­ni­zation’s exposure to hundreds, sometimes thousands, of risks, and clearly seeing how they interlink with one another—and can potentially set off a cascade of negative effects.

Packed with eye-opening case studies, engaging stories, and “lessons learned,” Fundamentals of Enterprise Risk Management helps you:

● Avoid the dire consequences of failing to recognize both your external and internal risk exposures.

● Set up a world-class ERM system using the practical strategies, helpful examples, and unique tools.

● Create a central, easy-to-use knowledge warehouse to share information and support decision-making.

● See and manipulate complex risk relationships using innovative visual software such as Riskonnect®.

● Exceed the monitoring requirements mandated by the Securities and Exchange Commission, Basel II, the Sarbanes-Oxley Act—and much more.

Most helpful customer reviews

9 of 9 people found the following review helpful.
Excellent Foundation Book for New ERM Managers
By Justin S
I purchased this book to gain foundation knowledge in ERM and Corporate Risk Management. My greatest concern with these types of texts is that they provide tons of theory and little practical application. I selected this book because NC State has it as a suggested reading for its ERM Masters courses.

Bottomline, if you are looking for a book to give you the theory and then provide concrete practical application, this is the book you want. If you are looking for a starting point to get your hands around the major topis of ERM, this is the book you want. Basically, the text allowed me to diagram a future state ERM program for my company, and challenge potential consultants to work with us on the implementation project.

Very well written.

0 of 0 people found the following review helpful.
I actually would have given it only 3.5 Stars
By Carl Kirstein
What I really like about this book is the snippets of case studies throughout. Many books talk about what risk managers did wrong, but Hampton talk more about what the risk managers have done right. There are many ways to do something wrong, but not many ways to do something right. This is what tipped the scale for me from 3 stars to 4 stars. What I have also appreciated is that Hampton spent time to write about what the organization should look like to manage risks.

Other than that the book is not contributing much more. It gives average views on the types of risk you could encounter and how to manage a risk database (the Riskonnect tool being developed), with the dependencies between the risks. I feel however that it fell short in the database and dependencies that have been presented. All the risks are treated qualitatively, and as exact/precise figures instead of uncertainties. Also the relationships between the risks are not properly formulated (using formulas or some kind logic such as boolean).

For the case studies alone I would recommend this book, but I would recommend other sources for the risk analysis portions.

0 of 0 people found the following review helpful.
Fun but useless
By Dmitri
This book is a collection of stories and surveys. Although it might be usefull for idea generation purposes and as a general weekend read , I found it useless in my practice as a risk manager.

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• Sales Rank: #253356 in Books
• Brand: Brand: Mosby
• Published on: 2008-08-05
• Ingredients: Example Ingredients
• Original language: English
• Number of items: 1
• Dimensions: 1.10" h x 8.50" w x 10.70" l, 4.00 pounds
• Binding: Paperback
• 736 pages

Features

• The human brain
• Brain functional anatomy
• Neuroscience
• Sixth edition

Review

"The illustrations were excellent and did add to the readability and understanding of the content. The manner with which the author tried to involve the reader with the content was also very good. It is a very well-presented book, and published and printed to a very high standard." BMA Book Awards 2009 - judges comments

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2 of 2 people found the following review helpful.
New changes since my last edition
By Thought
I have read prior edition of this cover to cover many times in my work. Use it as a reference very often. Much of the brain is still unknown - this text allows good footprints for your thought process in what is known and unknown. the images are of an older style - no fancy 3d rendered artwork - but this allows your mind to fill in and 'build' what you are also reading.

any physician of medicine or provider of healthcare should have read one of these from start to end at least once. I do not think you have to have the most current version - as there are updates from older versions - but this work is mostly related to aspects of brain structure and function that have not changed much over a few versions.

0 of 0 people found the following review helpful.
Five Stars
By Amazon Customer
Fast shipping. Item as described. Thanks!

2 of 2 people found the following review helpful.
great for any discipline
By Kate E
I used this textbook for a neuro course in a speech pathology master's program, and I found that the writing was clear and very readable even without an extensive medical background. Probably not a good textbook if you've never taken a class on brain-related things, but even with my limited background I was able to understand it. The illustrations are really wonderful and they don't skimp on color! I actually looked forward to the reading for this class because the book was so clear and even entertaining at times.

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Nolte's The Human Brain: An Introduction to its Functional Anatomy With STUDENT CONSULT Online Access, 6e (Human Brain: An Introduction to PDF
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[F825.Ebook] Ebook Download The Painted Cat, by Austen Crowder

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The Painted Cat, by Austen Crowder

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Janet lives in two worlds.

In one world, she is Miss Perch, teacher at a small school deep in the corn grids, helping kids who are turning into cartoon find their way out of town.

In the other, she is Bunny Cat, and paints herself up to be the very same type of cartoon cat her small town has grown to hate.

The wall separating those two worlds is starting to break down. Between rekindling a relationship with an old college flame and discovering how much she loves being Bunny Cat her two worlds are starting to merge. Keeping up the appearances of two separate lives is bad enough, but when kids start getting sent away for turning toon she knows she can’t stand on the sideline any longer.

Two things are for sure: the two worlds won’t stay distinct for much longer, and Janet won’t come out unscathed.

The Painted Cat is the second novel from Austen Crowder.

• Sales Rank: #433297 in eBooks
• Published on: 2015-05-09
• Released on: 2015-05-09
• Format: Kindle eBook

Most helpful customer reviews

1 of 1 people found the following review helpful.
This book is written by one of my favourite authors. Austen builds on the world she created ...
By Gina Bennett
This book is written by one of my favourite authors.

Austen builds on the world she created in Bait and Switch and once again keeps you hanging on to every word, wondering what's going to happen next. Sh uses the Toon World as a way to parallel the struggles of the LGBT community and th struggles they can face.

Janet struggles with relationships and with her inner identity, trying to figure out a way to balance who she is and who people expect her to be.

Seriously awaiting the third book in the series.

WAY TO GO, AUSTEN!

1 of 1 people found the following review helpful.
Excellent book. Takes you back into the world from ...
By Jacob Wilson
Excellent book.

Takes you back into the world from Bait and Switch. Strong and thought provoking writing. Really made the characters come alive. Read it in just over a day, was very hard to put down.

The subject matter was great, really taking hold to mirror whats happening in our world in its own way.

I highly recommend. You couldn't go wrong with this one, read it.

0 of 0 people found the following review helpful.
A unique and fascinating world
By Jennifer D. Reitz
An excellent companion novel to 'Bait and Switch' Crowder's unique take on a reality where humans can transform into cartoons is exquisite. More than a simple fantasy, Crowder uses the transformational conceit to explore the issues that gender nonconforming people endure within our own world. But more than this, Crowder's worldbuilding takes a universe not unlike that depicted in Rodger Rabbit into entirely new and daring territory in entirely new and astonishing directions.

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[A122.Ebook] Ebook Free Welcome to Camp Slither (Goosebumps Horrorland #9), by R.L. Stine

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It's a whole new ride from master of horror and bestselling author R.L. Stine--with a story so fiendish that it can't be contained to just one book!

Boone and Heather are psyched for summer camp. The legends of man-eating snakes and disappearing campers are hisss-terical! Sure, it's strange that the camp lotion makes their skin peel, but there's a good explanation, right? Right?!

Things get even wrose when Boone joins the other eleven Very Special--And Very Terrified!--Guests at HorrorLand. There's something Very Wrong about a bumper-car ride called the R.I.P.P.E.R...

• Sales Rank: #279940 in eBooks
• Published on: 2015-02-24
• Released on: 2015-02-24
• Format: Kindle eBook

About the Author
R.L. Stine's books have sold more than 300 million copies, making him one of the most popular children's authors in history. Besides Goosebumps, R.L. Stine has written series including: Fear Street, Rotten School, Mostly Ghostly, The Nightmare Room, and Dangerous Girls. R.L. Stine lives in New York with his wife, Jane, and his King Charles spaniel, Minnie. www.RLStine.com.

Most helpful customer reviews

5 of 6 people found the following review helpful.
Will Be Embraced By Goosebumps Horrorland's Many Fans
By KidsReads
Boone Dixon and his sister, Heather, are pretty excited about their upcoming adventure at Camp Hither. Heather immediately makes friends on the camp bus, while Boone is sitting near the palest boy he's ever seen. Oddly, the boy, who says his name is Roddy, is clutching a rabbit's foot. Roddy seems to think he will need some extra luck at Camp Hither. He tells Boone about the scary things he's heard about the camp. Supposedly, the counselors make the campers swim across a lake filled with snakes. Boone tries to reassure Roddy, saying that people are teasing him. But Roddy remains obviously terrified.

Boone scoffs at Roddy's notions, but is surprised when he asks the busload how many of them have previously camped at "Camp Slither." Not one person has been there before; they are all newcomers. Still, Roddy's fears seem even more unfounded when he screams "Snake!" at the rattle of Heather's bracelet. Obviously, Roddy is just the nervous type.

Of course, Roddy finds great significance in the head counselor's name: Dr. Crawler. But Boone tells him it's just a name. Nathan, their cabin counselor, brushes off Roddy's fears, too. He offers to take Roddy snake hunting, to the nervous camper's horror. When the nurse sprays them with sunscreen, she assures them that the camp staff all want the campers to stay safe. Nothing makes Roddy feel safe, though. And when Boone, Roddy and their fellow cabin-mates goof around by spraying each other with the sunscreen the nurse gave them, Boone finds it slightly odd that his skin turns scaly...and strips of it begin to peel away. However, he persuades himself that it's just a case of dry skin.

At the first meeting of the campers, even Boone is dismayed at the noise he and Roddy hear. It's the loudest hissing you can imagine. When Roddy asks Dr. Crawler what the sound is, the counselor claims it's just crickets. No one is buying that explanation. Boone begins to wonder: Is the hill they're on crawling with creepy, slithering snakes? And when Dr. Crawler proclaims that the big event of their camp stay will be the swimming race across Lake Hither, Boone can't help but think of the story Roddy told him on the bus.

When the boys go on a hike with Nathan, Roddy points to a deep rut in the side of the lake, suggesting it's the track of a giant snake. Nathan pulls a prank that scares both Roddy and Boone. Afterward, Roddy says he's going back to the cabin. Little does Boone realize the significance of that leave-taking until later --- but by then he'll be too scared to do much beyond trying to survive.

WELCOME TO CAMP SLITHER will be embraced by Goosebumps Horrorland's many fans, who will enjoy another episode of thrills and chills as Boone shares his terrifying tale. Of course, readers also are treated to the next chapter in the ongoing HorrorLand theme park story. Boone Dixon has a very special invitation waiting for him --- if he lives long enough to accept it.

--- Reviewed by Terry Miller Shannon

4 of 5 people found the following review helpful.
Creepy!
By Coffee Addicted Writer (Billy)
Boone and Heather are psyched about spending the summer at Camp Hitcher. They are told about the legends of the man-eating snakes, and about campers disappearing. Will they be next?

In the second story, Boone arrives in Horrorland and teams up with the other kids from the previous story.

"Welcome to Camp Slither" is a creepy tale that will make your spine tingle. It's a great story to tell in front of a campfire. I was disappointed that the character Heather didn't make into Horrorland.

2 of 2 people found the following review helpful.
Another great book from this series
By ssarcher
i purchased this book to add to my daughter's growing Goosebumps collection. The book was well written and she enjoyed the story. The book was received on time and in good condition.

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