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  • Iso 9001by Syed Imtiaz Haider

    CRC Press 2001; US$ 397.00

    Preface Introduction Objective What is Quality Correspondence Between ISO9001:1994 and ISO9001:2000 The Basic Changes Documentation & Registration/Certification Quality Manuals Model-1: Quality Manual ISO 9001:2000 Model-2: Quality Manual ISO 9001:2000 Model-3: Quality Manual ISO 9001:2000 Model-4: Quality Manual ISO 9001:2000 Standard Operating... more...

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

    CRC Press 2010; US$ 297.00

    About the Manual Objective Definitions Used Correspondence between ISO 14001:1996 & ISO 14001:2004 Correspondence between ISO 9001:2008 & ISO 14001:2004 Correspondence between ISO 14001:2004 and ISO 9001:2008 Certification Environmental Management System Manual (EMS) Environmental Management System Manual ISO 14001 Standard Operating Procedures... more...

  • Pharmaceutical Master Validation Planby Syed Imtiaz Haider

    CRC Press 2001; US$ 199.95

    INTRODUCTION Project Description What is a Validation Master Plan Scope of a Validation Master Plan Definition of the Term Validation Validation Team Members Validation Team Responsibilities CONCEPT OF QUALIFICATION / VALIDATION Fundamentals Concept of a Validation Life Cycle Elements of Qualification/Validation Documentation Format of Qualification... more...

  • Validation Standard Operating Proceduresby Syed Imtiaz Haider

    CRC Press 2006; US$ 252.00

    Introduction to Validation. Fundamentals of Validation SOPs. Validation Glossary. Calibration of Instruments. Training on the Job. Guidelines for Area Classification and Air Handling. Validation of a Steam Sterilizer. Kneading Machine. Blistering Machine. Installation Qualification of Computerized Equipment. Validation of Microbiological Methods. Vendor... more...

  • Biotechnologyby Syed Imtiaz Haider; Anika Ashtok

    CRC Press 2009; US$ 125.95

    Microbial Growth Text Culturing Microorganisms Text Bioreactor Configurations Text Bioreactor Design Features Text Lyophilization: Growing with Biotechnology Text Shear Effects in Culture Text Energy Input in Bioreactors Text Downstream Processing Text Mammalian Cell Cultures Text Plant Cell Cultures Text Fermentation... more...

  • Cleaning Validation Manualby Syed Imtiaz Haider; Syed Erfan Asif

    CRC Press 2010; US$ 167.95

    CLV-1 How to Establish a Cleaning Validation Program CLV-2 Introduction CLV-3 Scope and Approach CLV-4 Cleaning Validation Team Members and Responsibilities CLV-5 Cleaning Validation Philosophy, Strategies, and Methodology CLV-6 Planning Phase CLV-7 Execution Phase CLV-8 Analytical Testing and Reporting Phase CLV-9 Equipment Description CLV-10... more...

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

    CRC Press 2012; US$ 139.95

    Handling of Sampled Material Control of Incoming Materials used in Production Control of Bulk and Intermediate Products Checking of Finished Products Destruction of Disposal Samples after Complete Testing and Reference Samples after Expiry Recording the Analysis and Controlling the Analytical Registers and Records Testing of Finished Products Microbiological... more...

  • Quality Control Training Manualby Syed Imtiaz Haider; Syed Erfan Asif

    CRC Press 2011; US$ 159.95

    Preface Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products Analytical Methods and Techniques for Biological Products Laboratory Training Manual Assessment of Training Training Assessment with Quiz and Answers Training Log Analytical Method Validation Master Plan Analytical Methods Validation Protocol... more...

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