[PDF] Operational Member Qualification Guide eBook

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Boat Crew Seamanship Manual

Author : U.S. Coast Guard
Publisher : WWW.Snowballpublishing.com
Page : 902 pages
File Size : 41,95 MB
Release : 2012-08
Category : Reference
ISBN : 9781607964957

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The Boat Crew Seamanship Manual presents the approved methods and procedures for the conduct of Coast Guard boat operations. The Coast Guard Auxiliary, for the conduct of vessel facility operations, also uses this Manual.

Advanced Manufacturing Operations Technologies

Author : Sam A. Hout
Publisher : CRC Press
Page : 321 pages
File Size : 25,47 MB
Release : 2023-07-06
Category : Technology & Engineering
ISBN : 1000903931

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This book discusses and chronicles various types of manufacturing processes, including casting and molding, machining, joining, shearing, and forming. It refers to repetitive, discrete job shop process manufacturing (continuous) and process manufacturing (batch). It also offers detailed examples from the nuclear, electronic, plastics, adhesives, inks, packaging, chemical, and pharmaceutical industries. Advanced Manufacturing Operations Technologies: Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice fills the gap in the connection between production and regulated applications in several industries. It highlights established concepts and provides a new, fresh outlook by concentrating on and creating linkages in the implementation of practices in manufacturing and safe, clean energy systems. Case studies for the overall design, installations, and construction of manufacturing operations in various industries as well as the standard operating procedures are offered. The book also discusses the correlation between design strategies including step-by-step processes to ensure the reliability, safety, and efficacy of products. The fundamentals of controlled techniques, quality by design, risk assessment, and management are covered in support of operations applications and continuous improvement. This comprehensive book is helpful to all professionals, students, and academicians in many scientific disciplines that utilize fundamental principles of chemical engineering. It is engineering-driven and will be of use to those in industrial and manufacturing, chemical, biochemical, mechanical engineering, and automated control systems fields.

Practical Guide to Single-use Technology

Author : Adriana G Lopes
Publisher : Smithers Rapra
Page : 178 pages
File Size : 41,42 MB
Release : 2016-08-31
Category : Science
ISBN : 1910242047

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Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents:An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP;Strategy for standardisation of single-use bag systems and assessment of extractables and leachables;Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams;Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; andQualification approach for different SUT types.With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.

Digital adaptation kit for HIV: operational requirements for implementing WHO recommendations in digital systems

Author : World Health Organization
Publisher : World Health Organization
Page : 146 pages
File Size : 49,70 MB
Release : 2022-07-29
Category : Medical
ISBN : 9240054421

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Digital Adaptation Kits (DAKs) are part of the WHO SMART guidelines initiative and include data and health content consistent with WHO’s HIV recommendations that are generically applicable to digital systems. They are software-neutral, operational, and structured documentation based on WHO clinical, health system and data use recommendations to systematically and transparently inform the design of digital systems. The components include: (1) linked health interventions and recommendations; (2) personas; (3) user scenarios; (4) business processes and workflows; (5) core data elements mapped to standard terminology codes (e.g. ICD); (6) decision support; (7) programme indicators; and (8) functional and non-functional requirements. This DAK focuses on HIV testing, prevention, and treatment.