Gcp A Guide To Archiving
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Gcp A Guide To Archiving
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Author : Chris Jones
language : en
Publisher: Lulu.com
Release Date : 2014-07-16
Gcp A Guide To Archiving written by Chris Jones and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-16 with Science categories.
This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).
Gcp A Guide To Archiving
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Author : Chris Jones
language : en
Publisher: Lulu.com
Release Date : 2014-07-16
Gcp A Guide To Archiving written by Chris Jones and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-16 with Science categories.
This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).
A Guide To Archiving Of Electronic Records
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Author : Tim Stiles
language : en
Publisher: Lulu.com
Release Date : 2014
A Guide To Archiving Of Electronic Records written by Tim Stiles and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Language Arts & Disciplines categories.
The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with both Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The maintenance and retention of such records provides the means by which a study, trial, process or procedure can be reconstructed and thus enabling the information and results generated to be verified. Requirements for the operation of an archive and the archiving process for electronic records are no different to the requirement of physical records which are required to be retained for regulatory or business requirements. However, due to the variety and fragility of electronic records some additional features are required. The purpose of this document is to identify and discuss these features and provide guidance on how these challenges can be met.
Google Cloud Platform An Architect S Guide
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Author : Alasdair Gilchrist
language : en
Publisher: Alasdair Gilchrist
Release Date :
Google Cloud Platform An Architect S Guide written by Alasdair Gilchrist and has been published by Alasdair Gilchrist this book supported file pdf, txt, epub, kindle and other format this book has been release on with Computers categories.
Learn fundamental to advanced GCP architectural techniques using 30 + real-world use cases. The 'Google Cloud Platform an Architect's Guide' is a comprehensive handbook that covers everything that you need to know from GCP fundamentals to advanced cloud architecture topics. The book covers what you need to understand to pass the Google certification exams but goes far further and deeper as it explores real-world use cases and business scenarios. But you don't need to be an IT expert as the book is designed to cater for both beginners and those experienced in other cloud or on other on-premises networks. To that end, the book is split into distinct parts that caters for all levels of expertise. Part -1 is aimed at the novice someone new to a cloud architecture environment that needs to become familiar with the fundamentals of cloud architecture and industry best practices so the more experienced reader may wish to skip this section. Part-2 takes a far deeper dive into GCP theory and practice as well as providing real-world use cases and practical tips that are beneficial for architects at all levels. Part-3 delves much deeper into GCP practical theory on elasticity, scalability and resilience. It also covers Kubernetes in greater detail and touches on High-Performance Computing and IoT designs. The book closes with a final part dealing with cloud-native design practices and as such it covers design, monitoring, notification and remediation techniques to ensure best practice in cloud-native application design, deployment, stabilisation and commissioning.
Google Cloud Platform All In One Guide
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Author : Praveen Kukreti
language : en
Publisher: BPB Publications
Release Date : 2023-01-16
Google Cloud Platform All In One Guide written by Praveen Kukreti and has been published by BPB Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-16 with Computers categories.
Explore the Essential Concepts, Tools, and Services in GCP KEY FEATURES ● Build a solid foundation of the Google Cloud Platform. ● Work with different AI and Machine Learning services offered by Google Cloud. ● Learn how to use Google cloud services to build scalable apps. DESCRIPTION Google Cloud platform has a suite of cloud computing services for developing and maintaining software. It includes products like Google Compute Engine, Google App Engine, Google Cloud Storage, and Google Container Engine. With so much to offer, we will learn how to manage services running on Google Cloud. ‘Google Cloud Platform All-In-One Guide’ is primarily for everyone who wants to get familiar with the comprehensive list of services in GCP. You will work with various cloud-based services in computing, storage, database, and networking domains. You will understand how Big Data services can be used for developing end-to-end ETL/ELT pipelines. Lastly, you will explore various APIs available in Google cloud. The book ends with a chapter on best practices that will help you maximize resource utilization and cost optimization. By the end of the book, you will be able to design, develop, and deploy apps in GCP. WHAT YOU WILL LEARN ● Explore and work with security and monitoring services in Google Cloud. ● Learn how to build an ETL Pipeline in the Google Cloud Platform. ● Build and deploy code-based custom models using Vertex AI and Jupyter notebook. ● Learn how to create workflows using GCP services. ● Get an overview of best practices for securely deploying your workloads on Google Cloud. WHO THIS BOOK IS FOR This book is for everyone new to cloud computing or Google cloud. Cloud professionals who are looking to migrate their services to the Google cloud platform will find this book helpful. TABLE OF CONTENTS 1. Cloud Computing Fundamentals 2. Compute in Google Cloud 3. Storage in Google Cloud 4. Database Services in Google Cloud 5. Networking in Google Cloud 6. Security and Monitoring Services in Google Cloud 7. Big Data in Google Cloud 8. AI/ML in Google Cloud 9. Orchestration Services in GCP 10. Migration Services in GCP 11. Best Practices 12. Bonus Chapter 13. Use Cases
A Comprehensive And Practical Guide To Clinical Trials
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Author : Delva Shamley
language : en
Publisher: Academic Press
Release Date : 2017-06-07
A Comprehensive And Practical Guide To Clinical Trials written by Delva Shamley and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-07 with Medical categories.
A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. - Describes the entire clinical trial management process from start to finish in a step-by-step guide - Provides best practice elements, including case studies, practical examples, activities, and checklists
Guide For Clinical Trial Staff
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Author : Gerhard Fortwengel
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2004
Guide For Clinical Trial Staff written by Gerhard Fortwengel and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Medical categories.
The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.
Guide To Eu And Uk Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2023-01-10
Guide To Eu And Uk Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-10 with Law categories.
In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Guide For Investigator Initiated Trials
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Author : G. Fortwengel
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2011-04-04
Guide For Investigator Initiated Trials written by G. Fortwengel and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-04 with Medical categories.
For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.
Guide To Eu Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2017-02-17
Guide To Eu Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-17 with Law categories.
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.