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CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.

• Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action
• Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail
• Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately

• Sales Rank: #3371953 in Books
• Published on: 2015-12-25
• Original language: English
• Number of items: 1
• Dimensions: 9.10" h x .70" w x 6.00" l, .0 pounds
• Binding: Hardcover
• 248 pages

About the Author
Jackelyn Rodriguez has over 28 years of experience that cover all facets of quality assurance and regulatory compliance. Ms Rodriguez is the President of Monarch Quality Systems Solutions, a consulting firm serving in the technical and regulatory compliance capacity for several Pharmaceutical, Biologics and Medical Device manufacturers. Her consulting activities place emphasis on all aspects of regulatory compliance, training, Mock FDA audits/assessments, regulatory affairs and various FDA-related activities. Ms Rodriguez has published numerous compliance-related articles and has been a global industry speaker and presenter on several compliance topics. Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide. She has worked closely with CDRH’s FDA HACCP team for both promotion of Risk Management, training of over 1000 individuals, and worked with the FDA in their pilot study created to introduce the new Hazardous Analysis and Critical Control Points (HACCP) Inspection Technique to the Medical Device Industry.

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0 of 0 people found the following review helpful.
Five Stars
By Terry Edwards
Wonderful source for quality inspectors

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[U658.Ebook] Free PDF The Banker, by Leslie Waller

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• Sales Rank: #6883953 in Books
• Published on: 1991-04-04
• Format: Import
• Original language: English
• Dimensions: 4.37" h x 1.46" w x 7.01" l,
• Binding: Paperback
• 592 pages

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3 of 3 people found the following review helpful.
The Commercial Banks try to neutralize the Saving Banks' attempts for equalization.
By Dave Schranck
Of all the books and scripts Mr Waller had written in his lifetime, this is my favorite. The main protagonist is Woods Palmer, a Chicago banker from a family of Chicago bankers who is hired by the largest domestic bank from NYC as the number two man to foil the plot by Savings Banks to pass legislation enabling the Savings to grow beyond their current legal confinement in order to even the playing field with the Commercials.

The book was originally published in 1963 and the plot was a real life hot button issue of the day but with what has happened to this country in the last decade the book is showing its age and may seem a little docile. I believe the book still has relevance and that many people will still enjoy the story.
Besides the main plot, there are many sub plots, twists and turns, that will keep you turning the pages. Palmer is an accomplished banker but one that has lived under the shadow of his strict, old fashion father and must prove to himself that he is not only the equal but better than his father. You will also get to experience his unhappy family life with a wife who cares more for her social circle than her husband, Palmer's new love interest, Palmer's boss who is an old arrogant SOB who has become the leader of the movement to squash the Savings Banks that has been CEO of the largest bank too long and has lost sight of the realities of the day. There are also politicans, wheeler dealers and news people who are looking out for themselves as well.

While Palmer is performing his assigned task with the Savings plot, he discovers his bank, United Bank, is under attack and there is an ingenious plot to take over the bank. His solution to save the bank is also ingenious. While you're reading about the exploits of Woods Palmer you will also have the opportunity to discover the traitors in United Bank that have gone over to the outside interest in taking over the bank.
The characterization of the dozen main characters and an equal number of smaller characters is in-depth and excellent and will give the reader a look into the lives of wealthy people with positions that have influenced our society for decades. You'll see the strengths and weaknesses of these people. The dialog is also good and worthy of the high status and sometimes deviousness of these characters.

Not wanting to give the whole story away, I've just scratched the surface but if you're looking for an involved story dealing with banking on a macro level that includes corporate and personal intrigue then this is worthy of your consideration.

2 of 3 people found the following review helpful.
Expose of Financial Evil-Doings by "Respectable" Banks
By A Customer
This book examines the process by which banks control businesses and BIG businesses control banks, all of them engaged in making money for themselves at the expense of their customers. I really like the way the author explains the ins and outs of this complicated financial world while keeping this exciting story going.

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[W547.Ebook] Download Ebook The Answer: Making Sense of Life, One Question at a Time, by Jennifer Krause

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A topical and timely exploration of the ten questions that shape readers' lives.

The Answer is not the last self-help book we'll ever need, but it is the first book to turn to when life inevitably asks a question and waits for the answer that we-and only we-can provide.

Living in a fear-saturated culture and feeling overwhelmed has us constantly looking for answers of all kinds-sprinting after anything and anyone to make us feel safe. The Answer liberates us from that constant fear and endless scurrying. By examining ten thought-provoking questions, The Answer offers an unexpected approach to discovering the truths, wisdom, and insights that will transform our lives in sustainable ways. By trusting questions as a driving, natural, and nourishing force in life, we can begin to trust ourselves to find the answers that are right for us.

• Sales Rank: #2985076 in Books
• Published on: 2007-10-02
• Released on: 2007-10-02
• Original language: English
• Number of items: 1
• Dimensions: 8.30" h x .87" w x 5.56" l, .88 pounds
• Binding: Hardcover
• 208 pages

About the Author
Jennifer Krause delivers spiritual insight in unexpected ways, whether speaking at Manhattan's 92nd Street Y or leading her popular series, "Oy Latte," at Joe, a Greenwich Village cafŽ, featured in O Magazine and New York Times. She is a frequent speaker across the country.

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9 of 9 people found the following review helpful.
Krause puts the "Self" back into "Self-Help"
By G. Rubinstein
The Answer is a beautiful gem of a book. Full of ancient and modern wisdom, from The Dalai Lama to Burt Bacharach, Jennifer Krause shows us there is inspiration in all things. The Answer taps into our modern anxiety that we want to be all things at all times and feel like failures most of the time. Ms. Krause infuses The Answer with humor and fascinating facts and quotes, making this "self-help" book just plain fun to read. However, it gets under your skin, makes you realise that one life-pattern does not fit all, that each of us has a special and unique place in this world, that sometimes it's okay to just be you. Unlike other self-help titles, this one does not give advice as to "how to get everything one wants in 30 days or less" format. It says to us all, you are the wisest person you know, listen to your inner self and you will know what to do. I felt very empowered by "The Answer".

6 of 6 people found the following review helpful.
Wisdom literature in the finest sense
By Amazon Customer
We need more books and more citizens like Rabbi Krause. Every day we watch our leaders, friends and selves stumble because the tough questions haven't been asked. Krause is aware that any answer is determined by the question. Oddly this has often been overlooked by those claiming to offer guidance. The Answer is thus not self-help, but wisdom literature, an ancient genre deserving of space on every bookshelf.

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[T887.Ebook] Download The Girl With All the Gifts, by M. R. Carey

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The USA Today bestseller
Melanie is a very special girl. Dr Caldwell calls her "our little genius."
Every morning, Melanie waits in her cell to be collected for class. When they come for her, Sergeant keeps his gun pointing at her while two of his people strap her into the wheelchair. She thinks they don't like her. She jokes that she won't bite, but they don't laugh.
The Girl With All the Gifts is a groundbreaking thriller, emotionally charged and gripping from beginning to end.

• Sales Rank: #1334 in Books
• Published on: 2015-04-28
• Released on: 2015-04-28
• Original language: English
• Number of items: 1
• Dimensions: 8.25" h x 1.25" w x 5.50" l, .0 pounds
• Binding: Paperback
• 448 pages

Review
"Original, thrilling and powerful."―The Guardian

"Unique and terrifying."―Booklist

"An instant favorite."―Boing Boing

"A great read that takes hold of you and doesn't let go."―John Ajvide Lindqvist, author of LET THE RIGHT ONE IN

"Heartfelt, remorseless and painfully human...as fresh as it is terrifying. A jewel."―Joss Whedon

"If you only read one novel this year, make sure it's this one, it's amazing."―Martina Cole

"One of the more imaginative and ingenious additions to the dystopian canon."―Kirkus

"...a brilliant work of science fiction, but even people who never read science fiction should absolutely read this one."―io9.com

About the Author
M.R. Carey is a pen name for an established British writer of prose fiction and comic books. He has written for both DC and Marvel, including critically acclaimed runs on X-Men and Fantastic Four, Marvel's flagship superhero titles. His creator-owned books regularly appear in the New York Times graphic fiction bestseller list. He also has several previous novels and one Hollywood movie screenplay to his credit.

Most helpful customer reviews

505 of 546 people found the following review helpful.
However many words there are for brilliant this is all of them!
By Liz Barnsley
Melanie is a very special girl. Dr Caldwell calls her ‘our little genius’. Every morning, Melanie waits in her cell to be collected for class. When they come for her, Sergeant keeps his gun pointing at her while two of his people strap her into the wheelchair. She thinks they don’t like her. She jokes that she won’t bite, but they don’t laugh. Melanie loves school. She loves learning about spelling and sums and the world outside the classroom and the children’s cells. She tells her favourite teacher all the things she’ll do when she grows up. Melanie doesn’t know why this makes Miss Justineau look sad.

So. Mr Carey. I have been waiting for another book in another series, some folks will know what I mean, but I thought hey, this one will do to be going on with. Especially when good blogger friend Kate waxed lyrical about it and told me I must read it. Frankly it wasnt a hard sell..

This is an INCREDIBLY difficult book to review without spoilers – I had no idea why Melanie was so special going in, and I’m not going to tell you either, but special she is. And not just because this is a clever, fascinating, addictive story about – ha see you nearly had me – its about THINGS OCCURRING - but because she is ridiculously easy to love, so well written is she. In fact all of the characters pop right off the page for one reason or another.You will either want to protect them with your life or shoot them in the head. Often with no inbetween.

Its a horror story. But not really. Its a fantasy. But then, no not really. There is certainly love there. And loss. And some stand out scene setting. And a heck of a lot of jaw dropping moments. And don’t start reading it just before bed time. You won’t sleep. For various reasons…not all of which will have to do with how eager you are to find out what happens.

When I read a book like this it reminds me why I love to read. Utterly compelling, taking you away from the madness of the real world and into the madness of another…offering a new twist on a popular theme and getting you right at the heart. RIGHT at the heart. Its only the end of January but I would be MOST surprised if this one doesnt end up in my top 5 of the year. And trust me, choosing last years top 5 was hard enough..

PLEASE be careful which reviews you read of this one before you dive in my reading friends. It really is best arrived at with a beautiful blissful ignorance.

Highly Recommended. HIGHLY.

Happy Reading Folks!

**HardBack Version purchased via Amazon UK**

263 of 285 people found the following review helpful.
An exceptional story, but ignore the synopsis; it's nothing like the writing in the book
By Inspiring Insomnia
The Girl with All the Gifts might be my favorite book of 2014 (so far). It’s certainly in my top 5. Before I discuss the book, I have to discuss the synopsis. I feel like I’ve been complaining about synopses a lot recently, usually because they don’t reflect the tone of the book. This is probably the most egregious example. The synopsis is written as though a very young child with a very limited vocabulary is speaking. You would rightfully assume that the book would be written in this same manner, but you would be wrong. WHY do marketers do this? Are they intentionally trying to turn off readers? I heard about this book from somewhere other than Goodreads, and I’m sure I would never had chosen to read it if he synopsis was all I had to go on. The main character is a 10 year old girl named Melanie, and I could understand the desire to write the synopsis in a young voice IF the MC had that same voice in a first person narrative. But that is not the case here. Melanie is a very intelligent girl, and the narrative is written with an intelligent tone in the third person and doesn’t reflect her voice at all.

Sorry to go on and on about this, but I don’t want the odd choice for the synopsis to discourage anyone from reading the book. Because ALL of you should want to read The Girl with All the Gifts, and I’m going to do my best to tell you why. I’m going to keep it vague, because you need to discover the secrets of the book for yourself.

The story is set in a post-apocalyptic society in the U.K. Melanie and other children attend school classes, which seems normal enough on the surface, but it soon become apparent that something is not quite right, both with the children and with this school. We get hints of the nature of these differences early on, but it takes some time to learn what caused the apocalypse and how Melanie’s world reached this point.

Melanie has what could be called a childhood crush on her favorite teacher, Miss Justineau. Miss Justineau sees something in Melanie that stands out from the other children, and she can’t help responding to Melanie’s adoration, even though she tries to keep an emotional distance. Miss Justineau differs greatly from the other adults in Melanie’s life who treat her with apathy, at best, and shocking cruelty, at worst. It’s not hard to see why Melanie feels such affection for her teacher. The scenes between Melanie and Miss Justineau are heat-breaking. Melanie craves physical and emotional affection, just like every child deserves. But Miss Justineau can only do so much without risking her life and Melanie’s.

The Girl with All the Gifts starts out so strongly, and I thought that there was no way the story could maintain this pace. I was wrong, because the latter part of the book was even better. Melanie makes a decision at the end that has enormous implications. It affected me so much that it took a little while before I could even pick up another book. But was it the right decision? I think so, but that doesn’t mean that I was emotionally prepared for it.

Public service announcement: The Girl with All the Gifts is published by Orbit, a division of Hachette, the publisher that Amazon is battling. If you choose to buy this book (and you should!). think twice about buying from Amazon. Aside from the obvious reasons, Amazon is selling this at list price. B&N, Powells, and possibly your local indie, too, are selling it for significantly less.

Note: I received an ARC from the publisher in exchange for an honest review.

128 of 143 people found the following review helpful.
Intelligent and well crafted genre fiction
By Sean the Bookonaut
Do yourself a favour and don’t read the back cover of The Girl With All The Gifts. It won’t ruin the story for you but to my mind, when an author goes to the trouble to set up a clever opening to a well ploughed genre and then marketing decides to undercut that by telling you exactly what the book is like, because hey the point is shifting books… well…

If you like post apocalyptic thrillers with a decent scientific conceit underpinning it and an engaging read, go out and buy this book. Go, do it now.

But if you if you don’t really care or if you are one of those folk who like to know what the story is about before you go and make your investment, read on. But I am going to spoil it. Well, spoil it as much as the back cover does anyway.

All Melanie has ever known, all that she can remember is her room, the classroom, the showers and the corridor. Each day men in uniform come and collect her and take her to the classroom. She has a few different teachers, but her favourite is Miss Justineau. Miss Justineau teaches them about poetry, and Greek myth. The other teachers tell them about the time before the Breakdown, before the Hungries and the wild Junkers.

The back cover of my edition of The Girl With All The Gifts quotes Jenny Colgan of the Sunday Times as labelling it “Kazuo Ishiguro meets The Walking Dead”. I haven’t read any Ishiguro but the link to The Walking Dead sits uncomfortably with me (but I understand it’s shorthand for “this book has Zombies, shambling fans of the Walking Dead will love it”) or certainly not the most apt genre comparison one could make. I’d say it shares a family resemblance to certain works by Richard Matheson.

So yes it has Zombies. It has survivor tension and there is a race on to find a cure for the Hungry pathogen. As much as I like The Walking Dead, The Girl With All The Gifts is a much tighter and tense piece of work(maybe this is where the Ishiguro reference exerts itself) . The action set pieces are limited and brutal but this book earns praise for the maintaining the tension between the Survivors and drip feeding information about the Breakdown and the work towards a cure. This is no endless trudge, this book has a resolution, it has a finishing point and if you are very clued in to the hints Carey drops you might anticipate it. Looking back it’s a wonderful structured book with characters that we want to succeed against the worst Hungries and Humanity can throw up. It’s that hope I think that in the end masks the clues that Carey has dropped.

From a gender perspective The Girl With All The Gifts was good. The lead character is a young girl. The two scientists at the base where the story begins are female, two of the named teachers are female. Of the main cast three out of the five are women. Plenty of women talking to women about things other than men, sometimes not nice things but…

I wouldn’t be surprised if we saw it movie form. I am not sure that it would survive the Hollywood concept of what makes for a good movie though. The Girl With All The Gifts is intelligent and well crafted genre fiction, and while I could put it down, it was very compelling and a joy to return to.

This copy was provided by the publisher.

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