Analysis & Pharmaceutical Quality Books

New and Published Books – Page 3

21. Pharmaceutical Project Management, Second Edition

    Edited by Anthony Kennedy

    Series: Drugs and the Pharmaceutical Sciences

    Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases...

    Published March 16th 2008 by CRC Press
22. Preparing for FDA Pre-Approval Inspections

    A Guide to Regulatory Success, Second Edition

    Edited by Martin D. Hynes

    Series: Drugs and the Pharmaceutical Sciences

    This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design,...

    Published March 4th 2008 by CRC Press
23. Clean-In-Place for Biopharmaceutical Processes

    Edited by Dale A. Seiberling

    Series: Drugs and the Pharmaceutical Sciences

    An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities....

    Published October 14th 2007 by CRC Press
24. Disinfection and Decontamination

    Principles, Applications and Related Issues

    Edited by Gurusamy Manivannan

    In the battle between humans and microbes, knowledge may be not only the best weapon but also the best defense. Pulling contributions from 34 experts into a unified presentation, Disinfection and Decontamination: Principles, Applications, and Related Issues provides coverage that is both...

    Published October 3rd 2007 by CRC Press
25. Validation of Pharmaceutical Processes, Third Edition

    Edited by James P. Agalloco, Frederick J. Carleton

    Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many...

    Published September 24th 2007 by CRC Press
26. Validation and Qualification in Analytical Laboratories, Second Edition

    By Ludwig Huber

    This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.  With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy...

    Published July 22nd 2007 by CRC Press
27. Pharmaceutical and Medical Device Validation by Experimental Design

    Edited by Lynn D Torbeck

    This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why...

    Published June 25th 2007 by CRC Press
28. Six Sigma in the Pharmaceutical Industry

    Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics

    By Brian K. Nunnally, John S. McConnell

    The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable...

    Published June 12th 2007 by CRC Press
29. Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition

    Edited by Stephen P. Denyer, Rosamund M. Baird

    Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological...

    Published December 25th 2006 by CRC Press
30. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

    Edited by Joseph D. Nally

    Series: Drugs and the Pharmaceutical Sciences

    With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and...

    Published December 25th 2006 by CRC Press