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Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. A companion CD contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for cGMP audit is also included based on risk management criteria. An exam complements the material included in the CD.

• Sales Rank: #2073573 in Books
• Published on: 2014-08-15
• Original language: English
• Dimensions: 10.00" h x 7.25" w x 1.25" l,
• Binding: Hardcover
• 396 pages

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Elaine flees a shapeless assassin through the tunnels of London's underground, and the Basanos moves to annex Lucifer's Cosmos. Meanwhile, Lucifer himself is fatally distracted by a declaration of war--from Mazikeen! "Paradiso" part 2.

• Sales Rank: #2225664 in eBooks
• Released on: 2014-02-04
• Format: Kindle eBook

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A collection of keynotes and talks delivered throughout 2015, this book explores the history of the future of education technology: its politics, its mythology, and its monsters.

• Sales Rank: #939469 in eBooks
• Published on: 2015-11-07
• Released on: 2015-11-07
• Format: Kindle eBook

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1 of 1 people found the following review helpful.
Informative, insightful and critically-needed views on education technology trends
By Cary K.
In the final keynote of The Revenge of the Monsters Of Education, Audrey Watters identifies two missing elements from the field of education technology: criticism and care. To me, the immense power of Watters' ideas can be found in those two words. In The Revenge of the Monsters of Education, Watters presents the often-overlooked negative implications of lauded education technology trends like automation, algorithms and personalization. She also boldly examines the effects of sexism, imperialism and systemic inequality within education technology on learners of all ages. While some of the keynotes have talking points that overlap, each piece brought me unique, provoking insights. Best of all, Watters' keynotes are well-researched and humorous, making them both informative and enjoyable, even if you don't agree with all of her views. Definitely worth the few dollars to download and support her work.

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Drawing on her years of experience as an Arabic instructor and course developer, Samia Louis has used a functional approach to create a bright, innovative set of coursebooks for the study of Egyptian colloquial Arabic the spoken dialect most frequently studied and most widely understood in the Arab world. Now three new books, for beginner, early advanced, and higher advanced students, have been added to the series. Designed according to the ACTFL guidelines for teaching Arabic as a foreign language, each book of Kallimni 'Arabi trains students through highly structured lessons in the crucial skills, with particular emphasis on listening and speaking, using real-life situations and expressions. The accompanying audio CD carries recordings of the dialogs and exercises in each chapter, made by Egyptian native speakers.

• Sales Rank: #254317 in Books
• Published on: 2009-03-01
• Original language: English
• Number of items: 1
• Dimensions: 6.70" h x .80" w x 9.50" l, 1.30 pounds
• Binding: Paperback
• 268 pages

Review

"The books in the [Kallimni 'Arabi] series altogether present the best Arabic textbooks available . . . miles ahead of most others."David Wilmsen, American University of Beirut

About the Author

Samia Louis has taught Arabic for fifteen years with the International Language Institute (ILI) in Cairo, an affiliate of the International House World Organization. She is also a writer and course developer.

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0 of 1 people found the following review helpful.
I would not recommend this book without an instructor or without the guidance ...
By Amazon Customer
Its meant for immersion. I would not recommend this book without an instructor or without the guidance of a native speaker. While the content isn't hard do not be decieved (95%+) almost all the book is in Arabic including the instructions. If you are planning self study to start I would recommend alif baa + al kitaab or The standard Arabic elementary - intermediate for beginning to learn.

23 of 24 people found the following review helpful.
Good/bad
By Shon R. Edwards
I had mixed feelings about this book. Maybe two stars is too generous. Although it seems to cover Egyptian Arabic topics that would be good in a text book, it's hard to tell, because all of the instructions are in Arabic as well! I know that this is a tactic used by many who write foreign language texts. I should know; I own literally hundreds, and speak many of the languages. But in this instance, for me, nothing was intuitive enough to even know where to begin. I needed it for a class and the teacher was somewhat fit to be tied, as well. She was openly frustrated by this fact and would have to translate the instructions for every single exercise she wanted us to do in the book. Just this one fact can take a five star book to nothing pretty fast. No sense in buying a "good" book you can't use. Save your money, if you can.

20 of 21 people found the following review helpful.
Excellent book but not for self study
By Khalid Ikram
As with the rest of the books in this series, the present volume lays out a very useful course for the practical study of the Egyptian dialect of Arabic. The vocabulary is high-frequency, and the expressions taught are those in common use.

The book appears to be primarily designed for use in the courses taught in the International Languages Institute (ILI) in Cairo; so only a minimal amount of support (one CD, no answers to exercises, no explanation in English) is provided. Thus the book would probably be excellent if used with a teacher, but is unlikely to be helpful to someone working on his/her own. I would give it four stars if used with a teacher, but only two for use in self-study.

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• Published on: 1941
• Binding: Hardcover

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