Gcp Quality Audit Manual
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Author | : Leonard Steinborn |
Publisher | : CRC Press |
Total Pages | : 633 |
Release | : 2019-04-23 |
Genre | : Medical |
ISBN | : 0429525826 |
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these
Author | : James E. Sayre |
Publisher | : Interpharm CRC |
Total Pages | : 151 |
Release | : 1994-02 |
Genre | : Clinical trials |
ISBN | : 9780935184563 |
Author | : Alain Spriet |
Publisher | : LIBRAIRIE LUGINBUHL |
Total Pages | : 294 |
Release | : 2005 |
Genre | : Medical |
ISBN | : 9783805577243 |
This new edition of `Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud
Author | : Vera Mihajlovic-Madzarevic |
Publisher | : John Wiley & Sons |
Total Pages | : 186 |
Release | : 2010-09-29 |
Genre | : Medical |
ISBN | : 0470920882 |
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
Author | : Philip Carson |
Publisher | : Royal Society of Chemistry |
Total Pages | : 657 |
Release | : 2007-10-31 |
Genre | : Science |
ISBN | : 1847557724 |
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.
Author | : Phillip A. Carson |
Publisher | : Royal Society of Chemistry |
Total Pages | : 657 |
Release | : 2007 |
Genre | : Science |
ISBN | : 0854048340 |
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.
Author | : Graham Ogg |
Publisher | : CRC Press |
Total Pages | : 229 |
Release | : 2005-11-01 |
Genre | : Medical |
ISBN | : 104006163X |
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
Author | : International Validation Forum |
Publisher | : CRC Press |
Total Pages | : 1114 |
Release | : 2024-11-15 |
Genre | : Science |
ISBN | : 1040280684 |
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Author | : International Validation Forum |
Publisher | : CRC Press |
Total Pages | : 860 |
Release | : 1996-04-10 |
Genre | : Science |
ISBN | : 9780824797461 |
This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.
Author | : Menghis Bairu |
Publisher | : Academic Press |
Total Pages | : 332 |
Release | : 2012-06-12 |
Genre | : Medical |
ISBN | : 0124158609 |
Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. - Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world - Provides real world international examples which illustrate the practical translation of principles - Includes forms, templates, and additional references for standardization in a number of global scenarios