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Home > All Products > Special Edition: Analytical Methods Validation, Vols I and II Combo
Special Edition: Analytical Methods Validation, Vols I and II Combo
List Price: $398.00
Price: $259.00
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Item Number: IVTZAMC
Purchase the combination of Analytical Method Validation Books for Pharmaceutical Firms titled “Special Edition: Analytical Methods Validation, Vols I and II Combo” for $259.00 from IndustryMatter.com.
These 2 comprehensive handbooks are excellent reference guides for pharmaceutical industry professionals and cover technical topics such as development and validation of analytical methods, analytical method validation for biopharmaceutical, analytical techniques, pharmaceutical and biologics quality control. Regulatory topics include FDA and pharmaceutical industry analytical method validation issues and adequately validated methods for approvable regulatory filings.
Pharmaceutical industry insiders and analysts understand the importance of defining a master plan to validate an analytical or bioanalytical method. These books in handbook format are essential analytical method validation resource guides for pharmaceutical businesses.
These handbooks were compiled from articles and papers published by the Institute of Validation Technology for use by representatives of the pharmaceutical industry along with pharmaceutical executives, pharmaceutical technology professionals, laboratory managers, pharmaceutical scientists and pharmaceutical engineers that work at pharmaceutical and biotechnology companies.
Analytical Method Validation Special Edition Validation of analytical methods includes both regulatory and technical objectives. It has received increased attention throughout the healthcare industry due to the FDA's focus during recent inspections. Companies often neglect this critical category in their master plan and validation programs.
Volume I Topics include:
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Analytical Method Validation Validation of Analytical Methodology
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Defining a Master Plan for the Validation of Analytical Methods
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Biological Method Validation: A Practical Approach
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FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry
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Suitability of Analytical Methods for Stability Testing - Is There Room for Improvement?
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A Step-by-Step Approach to Establishing a Method Validation Program
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Guidance for Industry: Bioanalytical Methods Validation
Volume II Topics include:
- A Step-by Step Approach to Establishing a Method Validation Program
- Good Analytical Method Validation Practice: Setting Up for Compliance and Efficiency: Part I
- Good Analytical Method Validation Practice: Deriving Acceptance Criteria for the AMV Protocol: Part II
- Good Analytical Method Validation Practice – Data Analysis and the Analytical Method Validation Report: Part III
- Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry
- FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry These articles were provided to IVT by leading validation professionals, and are now compiled as a single, easy-to-use resource to assist you in your method validation processes.
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