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Jumat, 16 April 2010

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Product details

File Size: 2859 KB

Print Length: 336 pages

Publisher: Concordia Publishing House; 2 edition (August 20, 2015)

Publication Date: August 20, 2015

Sold by: Amazon Digital Services LLC

Language: English

ASIN: B0147VCDMK

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We are using Lutheranism 101 for a midweek Bible class at our church. This is a good product from CPH. Several writers contributed to this project. They each had some good discussion prompting questions in each chapter of the Course book. Lutheranism 101 is very . . . Lutheran (Missouri Synod). That's not a problem for us (Chapter 15 "What About Women " may be a problem for some). We are pleased with this course. The "Answer Book" is available for free on line. Thanks for this resource CPH!

Finally! A book that openly defines and sources all the values of a Christian Denomination. The volume of information presented makes "Lutheranism 101" a slower read than a recreational novel but the format and, particularly, the content provide an easier and more interesting read than a text or reference book. I am a newcomer to the Lutheran Church, Missouri Synod, but not new to Christianity by any means. I am enjoying this publication the first time through and will definitely rely on it as a future reference. I sincerely believe that this book belongs in the library of anyone researching mainline Christian churches and lifelong members of the Lutheran Church, regardless of the parent synod.

This course provided a wonderful basic introduction into Christianity. The discussion of Lutheranism is based on the writings of Dr. Martin Luther and not on the ideas of some 21st century theologian pontificating on what he might wish were in the writings of Luther or in the pages of the Bible. Well worth the effort.

The comment that I put in for THE COURSE is the comment that was supposed to go in here. I looked at them wrong. THE COURSE is a good tool to use in conjunction with Lutheranism 101. And in case you did not read my other comment I highly recommend Lutheranism 101. It's easy to read and easy to understand. We use it as a group on Tuesday nights and everyone says that they all like it.

Don't think that this is "Lutheranism for Dummies" because that assumption would understate the value of this book. In part it is written for those who are wanting to understand Lutheranism but have no clue what it is, however, it is also a book that is excellent for all levels of understanding. It helps clarify the foundational beliefs of Lutherans in an easy to interalize manner. It is a good tool for those wanting to lead others to Christ, for those who want to explain the differences between true Christianity as compared to religions that focus on self, good deeds or a self-described concept of God. It helps the reader to understand Luther's lifelong desire to bring the love of Christ to all people, the need for constant and reverent prayer and the belief in our salvation, forgiveness of our sins and eternal life through Christ Jesus.

Great book. As a lifelong confessional Lutheran, I didn't think I would get much from this book, but it was good to go back and look at Lutheranism at its basics. Grace alone through faith alone by Christ alone.

That's not really a knock on the book, just to give you a hint of the format. I am not crazy about that kind of format but I know lots of people are. The content seems excellent from my perusal but that's all I can do with this kind of format:peruse it. 5 stars for content with 1 star for format with the caveat that I now many (younger?) people like this.

It goes through A- Z and Is put in layman's language. It covers all you will need to be a good Lutheran. Good Manuel for restudy and help you spread the word with real knowledge.

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Rabu, 14 April 2010

Download PDF Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif

Download PDF Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif

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Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif

Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif


Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif


Download PDF Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif

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Quality Operations Procedures for Pharmaceutical, API, and BiotechnologyBy Syed Imtiaz Haider, Erfan Syed Asif

To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance.

The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries.

The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.

  • Sales Rank: #3657520 in Books
  • Brand: Brand: CRC Press
  • Published on: 2012-06-06
  • Original language: English
  • Number of items: 1
  • Dimensions: 10.25" h x 7.00" w x 1.25" l, 2.65 pounds
  • Binding: Hardcover
  • 584 pages
Features
  • Used Book in Good Condition

About the Author

Syed Imtiaz Haider, Ph.D. is a quality assurance and environmental specialist with over 20 years of experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and in-process control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, biological analysis, method validation, biosimilars comparative studies, organizing preclinical studies, and preparation of the Central Technical Dossier (CTD) formatted for regulatory submission. He is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development.

Erfan Syed Asif, Ph.D. has over 17 years of experience in various areas of quality operations in pharmaceutical industries in Pakistan, the United States, Canada, and the UAE. He has worked in US FDA- and Health Canada–approved facilities in managerial positions under the quality operations umbrella. He has extensive experience in overseeing qualification projects for manufacturing equipments, utilities, systems, sterilization techniques, aseptic processes simulation test, and the sterile and nonsterile products manufacturing process.

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