Author: United States. Bureau of Employment Security
Publisher:
ISBN:
Category :
Languages : en
Pages : 116

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Book Description

Author: Craig Silverman
Publisher:
ISBN: 9781312023130
Category : Attribution of news
Languages : en
Pages : 120

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Book Description

Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 142001448X
Category : Medical
Languages : en
Pages : 218

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Book Description
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.

Author: United States Employment Security Bureau
Publisher:
ISBN:
Category :
Languages : en
Pages : 96

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Book Description

Author: United States. Bureau of Employment Security
Publisher:
ISBN:
Category : Employment agencies
Languages : en
Pages : 116

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Author:
Publisher:
ISBN:
Category : Employment agencies
Languages : en
Pages : 60

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Book Description

Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062

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Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 0824706897
Category : Science
Languages : en
Pages : 226

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Book Description
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

Author: S. Scandizzo
Publisher: Springer
ISBN: 1137436964
Category : Business & Economics
Languages : en
Pages : 242

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Book Description
This book is a one-stop-shop reference for risk management practitioners involved in the validation of risk models. It is a comprehensive manual about the tools, techniques and processes to be followed, focused on all the models that are relevant in the capital requirements and supervisory review of large international banks.

Author: Robert Packard
Publisher:
ISBN: 9780967311524
Category :
Languages : en
Pages : 258

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Book Description
Reference text on validation processes for manufacturing medical devices.