Mike Long – författare

Sets forth tested and proven risk management practices in drug manufacturingRisk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing.Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applicationsTested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processesRecent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturingCase studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturingBibliography and extensive references leading to the literature and helpful resources in the fieldWith its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

This book offers an in-depth explanation of Task-Based Language Teaching (TBLT) and the methods necessary to implement it in the language classroom successfully. Combines a survey of theory and research in instructed second language acquisition (ISLA) with insights from language teaching and the philosophy of educationDetails best practice for TBLT programs, including discussion of learner needs and means analysis; syllabus design; materials writing; choice of methodological principles and pedagogic procedures; criterion-referenced, task-based performance assessment; and program evaluationWritten by an esteemed scholar of second language acquisition with over 30 years of research and classroom experienceConsiders diffusion of innovation in education and the potential impact of TBLT on foreign and second language learning