Home | Amazing | Today | Tags | Publishers | Years | Account | Search 
Analytical Method Validation and Instrument Performance Verification

Buy
Teaches proper procedures for using tools and analytical methods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes:

  • Method validation of potency, related substances, and dissolution testing
  • Validation for pharmaceutical excipients, heavy metals, and bioanalysis
  • Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters
  • The LCMS system calibration
  • Proper environmental chamber qualification
  • Entire qualification process for computer equipment, hardware, and software
  • Validation of Excel spreadsheets
  • Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibration scientists, and research and development scientists.

About the Author
CHUNG CHOW CHAN is a Research Scientist at Eli Lilly Canada, Inc.

Y. C. LEE is the associate director of Patheon YM, Inc., in Canada.

HERMAN LAM is Manager of Automation and Lab Systems at Glaxo Smith Kline Canada.

XUE-MING ZHANG is a Supervisor at Novex Pharma. Chung Chow, Herman, and Y. C. are the founders of the Calibration and Validation Group (CVG). CVG is a scientific organization based in Canada that focuses on the advancement of the sciences in method validation and instrument qualification.

(HTML tags aren't allowed.)

Grome Terrain Modeling with Ogre3D, UDK, and Unity3D
Grome Terrain Modeling with Ogre3D, UDK, and Unity3D

Create massive terrains and export them to the most popular game engines

Overview

  • A comprehensive guide for terrain creation.
  • Step-by-step walkthrough of Grome 3.1 and toolset.
  • Export terrains to Unity3D, UDK, and Ogre3D.

In Detail

Grome...

Schaum's Outline of Beginning Chemistry, 3rd edition
Schaum's Outline of Beginning Chemistry, 3rd edition
This book is designed to help students do well in their first chemistry course, especially those who have little or no chemistry background. It can be used effectively in a course preparatory to a general college chemistry course as well as in a course in chemistry for liberal arts students. It should also provide additional assistance to students...
Virtual Networks: Pluralistic Approach for the Next Generation of Internet (ISTE)
Virtual Networks: Pluralistic Approach for the Next Generation of Internet (ISTE)
Currently, there is a strong effort on the part of the research community in rethinking the Internet architecture to cope with its current limitations and support new requirements. Many researchers conclude that there is no one-size-fits-all solution for all user, and network provider, needs, and thus advocate a pluralist network...

Female Pelvic Medicine and Reconstructive Pelvic Surgery
Female Pelvic Medicine and Reconstructive Pelvic Surgery

This text includes sections on anatomy, normal and abnormal physiology, investigation techniques, inflammatory conditions and treatment options. The international panel of contributors is at the forefront of research in the field; the editors have assembled these contributors and topics that span the entire range of pelvic floor disorders in...

Reinforcement Learning: State-of-the-Art (Adaptation, Learning, and Optimization)
Reinforcement Learning: State-of-the-Art (Adaptation, Learning, and Optimization)

Reinforcement learning encompasses both a science of adaptive behavior of rational beings in uncertain environments and a computational methodology for finding optimal behaviors for challenging problems in control, optimization and adaptive behavior of intelligent agents. As a field, reinforcement learning has progressed tremendously in the...

Bioprocessing of Renewable Resources to Commodity Bioproducts
Bioprocessing of Renewable Resources to Commodity Bioproducts

This book provides the vision of a successful biorefinery—the lignocelluloic biomass needs to be efficiently converted to its constituent monomers, comprising mainly of sugars such as glucose, xylose, mannose and arabinose. Accordingly, the first part of the book deals with aspects crucial for the pretreatment and hydrolysis of biomass...

©2019 LearnIT (support@pdfchm.net) - Privacy Policy