Method Validation in Pharmaceutical Analysis
Method Validation in Pharmaceutical Analysis

Author: Joachim Ermer

Publisher: John Wiley & Sons

Published: 2006-03-06

Total Pages: 418

ISBN-13: 3527604472

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Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Medical Device Software Verification, Validation and Compliance
Medical Device Software Verification, Validation and Compliance

Author: David A. Vogel

Publisher: Artech House

Published: 2011

Total Pages: 445

ISBN-13: 1596934239

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HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."

MySAP FI Fieldbook
MySAP FI Fieldbook

Author: Thomas Spitters

Publisher: iUniverse

Published: 2005-04

Total Pages: 120

ISBN-13: 0595350186

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Every day, organizations around the world use SAP (System Applications and Products in Data Processing) client/server systems. The basic enterprise resource planning software package offered by SAP consists of various modules that are specifically designed to direct a variety of important business functions: Financials (FI), Sales and Distribution (SD), Materials Management (MM), Controlling (CO), Asset Management (AM), Production Planning (PP), and Human Resources (HR). mySAP FI Fieldbook offers information technology professionals an in-depth look at the Financial (FI) module of this high-powered software. Author Thomas H. Spitters discusses a number of topics that will keep any company's SAP system running optimally, including strategies to guarantee: High availability High performance Data security mySAP FI Fieldbook is ideal for the new project team member, financial manager or controller, or any staff member in need of some immediate orientation with SAP's FI module. Discover everything you need to know about the powerful mySAP FI accounting function within this wide-reaching computing environment!

Statistical Design and Analysis in Pharmaceutical Science
Statistical Design and Analysis in Pharmaceutical Science

Author: Shein-Chung Chow

Publisher: CRC Press

Published: 2018-10-03

Total Pages: 581

ISBN-13: 1482273136

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"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

A Practical Field Guide for AS9100C
A Practical Field Guide for AS9100C

Author: Erik V. Myhrberg

Publisher: Quality Press

Published: 2010-02-08

Total Pages: 169

ISBN-13: 087389233X

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The purpose of this field guide is to assist the reader, step-by-step, in implementing a Quality Management System (QMS) in conformance with AS9100C. This field guide has been created in order to foster an inner-reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing a QMS but also for maintaining one. What separates this field guide from most other books on AS9100 and its implementation are the flow charts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. You need to turn out aerospace conforming parts on time, every time, and at a competitive cost, as that's exactly what the companies that can compete now and in the future will do. A Practical Field Guide for AS9100 will help to get you there.

Pharmaceutical Process Validation
Pharmaceutical Process Validation

Author: Robert A. Nash

Publisher: CRC Press

Published: 2003-03-27

Total Pages: 776

ISBN-13: 9780824708382

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The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Sterile Product Development
Sterile Product Development

Author: Parag Kolhe

Publisher: Springer Science & Business Media

Published: 2013-10-12

Total Pages: 590

ISBN-13: 1461479789

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This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Equipment Qualification in the Pharmaceutical Industry
Equipment Qualification in the Pharmaceutical Industry

Author: Steven Ostrove

Publisher: Academic Press

Published: 2019-06-13

Total Pages: 236

ISBN-13: 0128175699

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Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. - Incorporates good manufacturing processes into a compliant qualification program - Provides examples of protocol layout - Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Verification, Validation and Testing in Software Engineering
Verification, Validation and Testing in Software Engineering

Author: Aristides Dasso

Publisher: IGI Global

Published: 2007-01-01

Total Pages: 443

ISBN-13: 1591408512

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"This book explores different applications in V & V that spawn many areas of software development -including real time applications- where V & V techniques are required, providing in all cases examples of the applications"--Provided by publisher.