Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download The VALIDATE handbook PDF full book. Access full book title The VALIDATE handbook by Wija Oortwijn. Download full books in PDF and EPUB format.
Author: Wija Oortwijn Publisher: Radboud University Press ISBN: 9083178951 Category : Technology & Engineering Languages : en Pages : 173
Book Description
Health Technology Assessment (HTA) is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system. The definition reflects that facts and values are intertwined in HTA. This means that HTA should be considered as a type of policy analysis, wherein the assessment of safety, clinical and cost implications of health technologies, as well as their wider ethical, legal, social, organizational, environmental and other implications is conducted from the view that these aspects are closely interrelated, and wherein stakeholders are involved in a more productive way throughout the process of HTA. Acknowledging this holds the potential of conducting assessments of health technologies in a way that supports deliberative democratic decision making. In the 2018-2021 EU Erasmus+ strategic partnerships project “VALues In Doing Assessments ofhealthcare TEchnologies” (VALIDATE), a consortium of seven academic and HTA organizations have developed an approach to HTA that allows for the integration of empirical analysis and normative inquiry. The VALIDATE handbook: an approach on the integration of values in doing assessments of health technologies offers the reader an opportunity to get acquainted with the theoretical considerations and apprehend the associated practical and organizational implications of this approach. It offers those interested in HTA to integrate empirical analysis and normative inquiry in a transparent way.
Author: Wija Oortwijn Publisher: Radboud University Press ISBN: 9083178951 Category : Technology & Engineering Languages : en Pages : 173
Book Description
Health Technology Assessment (HTA) is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system. The definition reflects that facts and values are intertwined in HTA. This means that HTA should be considered as a type of policy analysis, wherein the assessment of safety, clinical and cost implications of health technologies, as well as their wider ethical, legal, social, organizational, environmental and other implications is conducted from the view that these aspects are closely interrelated, and wherein stakeholders are involved in a more productive way throughout the process of HTA. Acknowledging this holds the potential of conducting assessments of health technologies in a way that supports deliberative democratic decision making. In the 2018-2021 EU Erasmus+ strategic partnerships project “VALues In Doing Assessments ofhealthcare TEchnologies” (VALIDATE), a consortium of seven academic and HTA organizations have developed an approach to HTA that allows for the integration of empirical analysis and normative inquiry. The VALIDATE handbook: an approach on the integration of values in doing assessments of health technologies offers the reader an opportunity to get acquainted with the theoretical considerations and apprehend the associated practical and organizational implications of this approach. It offers those interested in HTA to integrate empirical analysis and normative inquiry in a transparent way.
Author: Michael E. Swartz Publisher: CRC Press ISBN: 142001448X Category : Medical Languages : en Pages : 218
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: James Agalloco Publisher: CRC Press ISBN: 1000436012 Category : Medical Languages : en Pages : 1062
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: S. Scandizzo Publisher: Springer ISBN: 1137436964 Category : Business & Economics Languages : en Pages : 242
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: Jerry Banks Publisher: John Wiley & Sons ISBN: 9780471134039 Category : Technology & Engineering Languages : en Pages : 868
Book Description
Dieses Buch ist eine unschätzbare Informationsquelle für alle Ingenieure, Designer, Manager und Techniker bei Entwicklung, Studium und Anwendung einer großen Vielzahl von Simulationstechniken. Es vereint die Arbeit internationaler Simulationsexperten aus Industrie und Forschung. Alle Aspekte der Simulation werden in diesem umfangreichen Nachschlagewerk abgedeckt. Der Leser wird vertraut gemacht mit den verschiedenen Techniken von Industriesimulationen sowie mit Einsatz, Anwendungen und Entwicklungen. Neueste Fortschritte wie z.B. objektorientierte Programmierung werden ebenso behandelt wie Richtlinien für den erfolgreichen Umgang mit simulationsgestützten Prozessen. Auch gibt es eine Liste mit den wichtigsten Vertriebs- und Zulieferadressen. (10/98)
Author: Priscilla Browne Publisher: Createspace Independent Publishing Platform ISBN: 9781548341442 Category : Languages : en Pages : 232
Book Description
Validation is a regulatory and legal requirement for the manufacture of medical devices and medicinal products. Validation is concerned with ensuring design requirements are fulfilled and that products are safely and consistently manufactured. It is a systematic and logical process. This book provides a concise overview and reference for engineers. It includes chapters on equipment and process validation and test method validation. Ancillary services and facilities are also reviewed in terms of typical deliverables.
Author: Gunter Jagschies Publisher: Elsevier ISBN: 0080554512 Category : Technology & Engineering Languages : en Pages : 383
Book Description
This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design
Author: James O. Westgard Publisher: AACC Press ISBN: 9781886958197 Category : Business & Economics Languages : en Pages : 292
Book Description
With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.
Author: Wija Oortwijn
Author: Wija Oortwijn
Author: Michael E. Swartz
Author: James Agalloco
Author: Robert Packard
Author: S. Scandizzo
Author: Craig Silverman
Author: Jerry Banks
Author: Priscilla Browne
Author: Gunter Jagschies
Author: James O. Westgard