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Book Synopsis Good Clinical, Laboratory and Manufacturing Practices by : Phillip A. Carson
Download or read book Good Clinical, Laboratory and Manufacturing Practices written by Phillip A. Carson and published by Royal Society of Chemistry. This book was released on 2007 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.
Book Synopsis Cloud Auditing Best Practices by : Shinesa Cambric
Download or read book Cloud Auditing Best Practices written by Shinesa Cambric and published by Packt Publishing Ltd. This book was released on 2023-01-13 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensure compliance across the top cloud players by diving into AWS, Azure, and GCP cloud auditing to minimize security risks Key FeaturesLeverage best practices and emerging technologies to effectively audit a cloud environmentGet better at auditing and unlock career opportunities in cloud audits and complianceExplore multiple assessments of various features in a cloud environment to see how it's doneBook Description As more and more companies are moving to cloud and multi-cloud environments, being able to assess the compliance of these environments properly is becoming more important. But in this fast-moving domain, getting the most up-to-date information is a challenge—so where do you turn? Cloud Auditing Best Practices has all the information you'll need. With an explanation of the fundamental concepts and hands-on walk-throughs of the three big cloud players, this book will get you up to speed with cloud auditing before you know it. After a quick introduction to cloud architecture and an understanding of the importance of performing cloud control assessments, you'll quickly get to grips with navigating AWS, Azure, and GCP cloud environments. As you explore the vital role an IT auditor plays in any company's network, you'll learn how to successfully build cloud IT auditing programs, including using standard tools such as Terraform, Azure Automation, AWS Policy Sentry, and many more. You'll also get plenty of tips and tricks for preparing an effective and advanced audit and understanding how to monitor and assess cloud environments using standard tools. By the end of this book, you will be able to confidently apply and assess security controls for AWS, Azure, and GCP, allowing you to independently and effectively confirm compliance in the cloud. What you will learnUnderstand the cloud shared responsibility and role of an IT auditorExplore change management and integrate it with DevSecOps processesUnderstand the value of performing cloud control assessmentsLearn tips and tricks to perform an advanced and effective auditing programEnhance visibility by monitoring and assessing cloud environmentsExamine IAM, network, infrastructure, and logging controlsUse policy and compliance automation with tools such as TerraformWho this book is for This book is for IT auditors looking to learn more about assessing cloud environments for compliance, as well as those looking for practical tips on how to audit them and what security controls are available to map to IT general computing controls. Other IT professionals whose job includes assessing compliance, such as DevSecOps teams, identity, and access management analysts, cloud engineers, and cloud security architects, will also find plenty of useful information in this book. Before you get started, you'll need a basic understanding of IT systems and a solid grasp of cybersecurity basics.
Book Synopsis Good Clinical, Laboratory and Manufacturing Practices by : Philip Carson
Download or read book Good Clinical, Laboratory and Manufacturing Practices written by Philip Carson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Book Synopsis Clinical Trials Audit Preparation by : Vera Mihajlovic-Madzarevic
Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Book Synopsis Good Clinical Practice eRegs & Guides - For Your Reference Book 2 by : eRegs & Guides
Download or read book Good Clinical Practice eRegs & Guides - For Your Reference Book 2 written by eRegs & Guides and published by eRegs And Guides. This book was released on 2013-11-22 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: E6 Good Clinical Practice Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application CFR 21-- General Part 11, Electronic Records; Electronic Signatures 21 CFR PART 50 Protection Of Human Subjects 21 CFR Part 54 Financial Disclosure By Clinical Investigators 21 CFR PART 56 Institutional Review Boards Title 21 PART 312 Investigational New Drug Application ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH E8 General Considerations For Clinical Trials
Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw
Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Book Synopsis Clinical Data Management by : Richard K. Rondel
Download or read book Clinical Data Management written by Richard K. Rondel and published by John Wiley & Sons. This book was released on 2000-02-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.
Book Synopsis Good Clinical Practice eRegs & Guides - For Your Reference Book 5 by : eRegs & Guides
Download or read book Good Clinical Practice eRegs & Guides - For Your Reference Book 5 written by eRegs & Guides and published by eregs & guides. This book was released on with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: Good Clinical Practice For Your Reference - Book 5 ICH - Efficacy Guidelines E3 – E15 ICH-E3: Clinical Study Reports ICH-E3 - Structure and Content of Clinical Study Reports ICH-E4: Dose-Response Information to Support Drug Registration ICH-E5: Ethnic Factors in the Acceptability of foreign Clinical Data ICH-E6: Guideline for Good Clinical Practice ICH-E7: Studies in Support of Special Populations: Geriatrics ICH-E8: General Considerations for Clinical Trials ICH-E9: Statistical Principles for Clinical Trials ICH E-10: Choice of Control Group and Related Issues in Clinical Trials ICH-E11: Clinical Investigation of Medicinal Products in the Pediatric Population ICH-E12: Draft ICH Consensus Principle Principles for Clinical Evaluation of New Antihypertensive Drugs ICH-E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs ICH-E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
Book Synopsis Cloud Native Automation with Google Cloud Build by : Anthony Bushong
Download or read book Cloud Native Automation with Google Cloud Build written by Anthony Bushong and published by Packt Publishing Ltd. This book was released on 2022-10-14 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by two Google Cloud experts, this book will help you to create a concrete foundation of Cloud Build so that you can define workflows and pipelines as builds in Google Cloud Build Key FeaturesLearn Cloud Build's API and build configuration/schemaApply scalability and security best practices for using Cloud BuildIntegrate Cloud Build with external systems critical to workflowsBook Description When adopting cloud infrastructure, you are often looking to modernize the automation of workflows such as continuous integration and software delivery. Minimizing operational overhead via fully managed solutions such as Cloud Build can be tough. Moreover, learning Cloud Build's API and build schema, scalability, security, and integrating Cloud Build with other external systems can be challenging. This book helps you to overcome these challenges by cementing a Google Cloud Build foundation. The book starts with an introduction to Google Cloud Build and explains how it brings value via automation. You will then configure the architecture and environment in which builds run while learning how to execute these builds. Next, you will focus on writing and configuring fully featured builds and executing them securely. You will also review Cloud Build's functionality with practical applications and set up a secure delivery pipeline for GKE. Moving ahead, you will learn how to manage safe roll outs of cloud infrastructure with Terraform. Later, you will build a workflow from local source to production in Cloud Run. Finally, you will integrate Cloud Build with external systems while leveraging Cloud Deploy to manage roll outs. By the end of this book, you'll be able to automate workflows securely by leveraging the principles of Google Cloud Build. What you will learnGet started with Cloud Build the right wayDefine new workflows using the Cloud Build schemaImplement a secure build and deployment environment for GKEAutomate serverless workflows for Cloud Run and Cloud FunctionsIntegrate Cloud Build with source code management and artifact storesDevelop a Cloud Build strategy for your organizationWho this book is for This book is for cloud engineers and DevOps engineers who manage cloud environments and desire to automate workflows in a fully managed, scalable, and secure platform. You are expected to have an understanding of cloud fundamentals, software delivery, and containerization fundamentals to get the most out of this book.
Book Synopsis Kubernetes Secrets Handbook by : Emmanouil Gkatziouras
Download or read book Kubernetes Secrets Handbook written by Emmanouil Gkatziouras and published by Packt Publishing Ltd. This book was released on 2024-01-31 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gain hands-on skills in Kubernetes Secrets management, ensuring a comprehensive overview of the Secrets lifecycle and prioritizing adherence to regulatory standards and business sustainability Key Features Master Secrets encryption, encompassing complex life cycles, key rotation, access control, backup, and recovery Build your skills to audit Secrets consumption, troubleshoot, and optimize for efficiency and compliance Learn how to manage Secrets through real-world cases, strengthening your applications’ security posture Purchase of the print or Kindle book includes a free PDF eBook Book DescriptionSecuring Secrets in containerized apps poses a significant challenge for Kubernetes IT professionals. This book tackles the critical task of safeguarding sensitive data, addressing the limitations of Kubernetes encryption, and establishing a robust Secrets management system for heightened security for Kubernetes. Starting with the fundamental Kubernetes architecture principles and how they apply to the design of Secrets management, this book delves into advanced Kubernetes concepts such as hands-on security, compliance, risk mitigation, disaster recovery, and backup strategies. With the help of practical, real-world guidance, you’ll learn how to mitigate risks and establish robust Secrets management as you explore different types of external secret stores, configure them in Kubernetes, and integrate them with existing Secrets management solutions. Further, you'll design, implement, and operate a secure method of managing sensitive payload by leveraging real use cases in an iterative process to enhance skills, practices, and analytical thinking, progressively strengthening the security posture with each solution. By the end of this book, you'll have a rock-solid Secrets management solution to run your business-critical applications in a hybrid multi-cloud scenario, addressing operational risks, compliance, and controls.What you will learn Explore Kubernetes Secrets, related API objects, and CRUD operations Understand the Kubernetes Secrets limitations, attack vectors, and mitigation strategies Explore encryption at rest and external secret stores Build and operate a production-grade solution with a focus on business continuity Integrate a Secrets Management solution in your CI/CD pipelines Conduct continuous assessments of the risks and vulnerabilities for each solution Draw insights from use cases implemented by large organizations Gain an overview of the latest and upcoming Secrets management trends Who this book is for This handbook is a comprehensive reference for IT professionals to design, implement, operate, and audit Secrets in applications and platforms running on Kubernetes. For developer, platform, and security teams experienced with containers, this Secrets management guide offers a progressive path—from foundations to implementation—with a security-first mindset. You’ll also find this book useful if you work with hybrid multi-cloud Kubernetes platforms for organizations concerned with governance and compliance requirements.
Book Synopsis Pharmaceutical Medicine and Translational Clinical Research by : Divya Vohora
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Book Synopsis The Pocket Guide to the EU Directives for Clinical Research by : Julie Meeson
Download or read book The Pocket Guide to the EU Directives for Clinical Research written by Julie Meeson and published by Inst of Clinical Research. This book was released on 2009 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Developing a Successful Clinical Research Program by : Cara East
Download or read book Developing a Successful Clinical Research Program written by Cara East and published by Springer. This book was released on 2018-08-08 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting.
Book Synopsis Hospitals and Nursing Homes by : Syed Amin Tabish
Download or read book Hospitals and Nursing Homes written by Syed Amin Tabish and published by Jaypee Brothers Medical Publishers. This book was released on 2021-07-02 with total page 1088 pages. Available in PDF, EPUB and Kindle. Book excerpt:
