Quality Assurance: Problem Solving And Training Strategies For Success In The Pharmaceutical And Li

Thảo luận trong 'Học tập' bởi eb2025, 21/5/2024.

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    20/5/2024
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    Quality Assurance: Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries
    By: Welty, G
    Publisher:
    Woodhead Publishing
    Print ISBN: 9781907568367, 1907568360
    eText ISBN: 9781907568367, 9781908818621, 190881862X
    Pages: 374
    Format: PDF
    Available from $ 240.00 USD
    SKU 9781907568367
    Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort.

    Presents a comprehensive view of the field of quality assurance
    An approach grounded in direct experience
    Uses diagrams and figures to clarify analytical points
     

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