Senin, 23 Juni 2014

[M344.Ebook] Ebook Free Magic Power of Self Image Psychology the New Way T, by Maxwell Maltz

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Magic Power of Self Image Psychology the New Way T, by Maxwell Maltz

  • Sales Rank: #3727833 in Books
  • Published on: 1964-06
  • Binding: Hardcover

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Sabtu, 14 Juni 2014

[Q822.Ebook] Download PDF Quality Operations Procedures for Pharmaceutical, API, and Biotechnology, by Syed Imtiaz Haider, Erfan Syed Asif

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



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Quality Operations Procedures for Pharmaceutical, API, and Biotechnology, by 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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0 of 0 people found the following review helpful.
Good starting point for SOPs
By Matt B
Good starting point for SOPs, but I don't think it's very in line with current industry practice in the U.S. Having the CD is very nice for traveling consultants.

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Rabu, 04 Juni 2014

[S633.Ebook] Ebook Download The Social Work Dissertation: Using Small-Scale Qualitative Methodology, by Malcolm Carey

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The Social Work Dissertation: Using Small-Scale Qualitative Methodology, by Malcolm Carey



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The Social Work Dissertation: Using Small-Scale Qualitative Methodology, by Malcolm Carey

The book guides the student through the research process relevant to the completion of a social work dissertation.

  • Sales Rank: #4420042 in Books
  • Published on: 2013-03-01
  • Released on: 2013-02-01
  • Original language: English
  • Number of items: 1
  • Dimensions: 3.58" h x .23" w x 2.36" l, .0 pounds
  • Binding: Paperback
  • 256 pages

About the Author
Malcolm Carey worked as a qualified social worker for seven years. He undertakes research and teaches on the MA in social work at the University of Manchester, UK.

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