The Validate Handbook
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Handbook of Analytical Validation
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.
Handbook of Validation in Pharmaceutical Processes, Fourth Edition
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
Handbook of Employee Selection
The Handbook of Employee Selection summarizes the state of science and practice in the field of employee selection. Chapters in this book cover issues associated with measurement such as validity and reliability as well as practical concerns around the development of appropriate selection procedures and implementation of selection programs. Several chapters discuss the measurement of various constructs commonly used as predictors, and other chapters confront criterion measures that are used in test validation. Ethical and legal concerns are dealt with in another set of chapters and highlight the concerns of the employer as well as the test taker and the psychologist responsible for the testing program. Final sections of the book include chapters that focus on testing for certain types of jobs (e.g., blue collar jobs, supervisory jobs) and describe important milestones in the development of selection programs.