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  • Validation Standard Operating Proceduresby Syed Imtiaz Haider

    Taylor and Francis 2001; US$ 259.95

    One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating... more...

  • Iso 9001by Syed Imtiaz Haider

    Taylor and Francis 2001; US$ 378.00

    Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series standards. It supplies ready to use ISO 9001:2000 Template... more...

  • Validation Standard Operating Proceduresby Syed Imtiaz Haider

    Taylor and Francis 2006; US$ 239.95

    Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations,... more...

  • Environmental Management System ISO 14001: 2004by Syed Imtiaz Haider

    Taylor and Francis 2010; US$ 283.00

    Environmental Management System ISO 14001:2004 provides the information and practical know-how required to facilitate a smooth adoption and incorporation of the latest revisions and enhancements put forth by the International Organization for Standardization. This unique work shows how to adopt or transition to the documentation procedures required... more...

  • Cleaning Validation Manualby Syed Imtiaz Haider; Syed Erfan Asif

    Taylor and Francis 2010; US$ 159.95

    During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use... more...

  • Quality Operations Procedures for Pharmaceutical, API, and Biotechnologyby Syed Imtiaz Haider; Erfan Syed Asif

    Taylor and Francis 2012; US$ 135.95

    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... more...

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