Download or read book Agent Gxp FDA Part 11 Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005-07 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Agent GXP FDA Part 11 teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. It is taught mostly through interactive questions and interviews with Agent GXP. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough course will teach you the history of Part 11, the regulations of Part 11, the implementation of Part 11, the applications of Part 11, the ideas behind Part 11 in order to apply them to new situations, and how to prepare for enforcement of Part 11. This is particularly important for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries, and provides an excellent glimpse of the issues that are likely to face HIPAA implementation of electronic records security measures. This course has been used by thousands of people in the pharmaceutical industry. Readers will enjoy the approachable, compact, conversational style of the title. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version. This is part of the highly acclaimed UniversityOfHealthCare series on FDA regulations.
Download or read book Part 11 and Computer Validation Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gives an introduction to computer issues in the pharmaceutical industry, as well as to computer systems validation. This work helps you learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and more. It is useful for research personnel in FDA-regulated industries.
Download or read book Agent GCP and the Bloody Consent Form Guidebook written by Daniel Farb and published by UniversityOfHealthCare. This book was released on 2005 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Agent GCP is THE way to learn FDA regulations. The exciting, suspenseful, and sometimes zany plot of a murder in a clinical trial is interweaved with interactivity and teaching of FDA regulations in an unforgettable manner. At the completion, learners will have obtained a superb knowledge of informed consent and IRB regulations. This course covers all the regulations on informed consent procedures and Institutional Review Boards (IRBs)—that is, Good Clinical Practices in 45 CFR 46, 21 CFR 50, 21 CFR 56, and other regulations. It is useful for any person or organization participating in clinical trials. The book contains useful aids including a glossary, a list of resources, model consent forms, and texts of regulations. Those readers who wish to have an accompanying program with interactivity should also purchase the CD version.
Download or read book Collaborative Process Automation Systems written by Martin Hollender and published by ISA. This book was released on 2010 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a comprehensive overview of the state-of-the-art in Collaborative Process Automation Systems (CPAS), this book discusses topics such as engineering, security, enterprise connectivity, advanced process control, plant asset management, and operator efficiency. Collaborating with other industry experts, the author covers the system architecture and infrastructure required for a CPAS, as well as important standards like OPC and the ISA-95 series of standards. This in-depth reference focuses on the differences between a CPAS and traditional automation systems. Implications on modern automation systems are outlined in theory and practice. This book is ideal for industrial engineers, as well as graduate students in control and automation.
Download or read book Powerful Medical Device Sales Guidebook written by Susan Postnikoff and published by UniversityOfHealthCare. This book was released on 2005-08 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide for the medical device and pharmaceutical sales representative on sales skills to use with doctors and hospitals while observing correct procedures and building trust. It covers the structure of a hospital, medical staff, the hospital pharmacy, hospital-based pharmacist, the nursing service, policies and procedures for hospital vendors.
Download or read book Innovative Process Development in Metallurgical Industry written by Vaikuntam Iyer Lakshmanan and published by Springer. This book was released on 2015-10-26 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the phases for innovative metallurgical process development, from concept to commercialization. Key features of the book include: • Need for process innovation • Selection and optimization of process steps • Determination of the commercial feasibility of a process including engineering and equipment selection • Determination of the environmental footprint of a process • Case-study examples of innovative process development
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
Download or read book Data Integrity and Compliance written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2019-05-08 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectationits a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sourcesincluding the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agencyinto a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.
Download or read book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations written by Orlando Lopez and published by CRC Press. This book was released on 2016-11-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.Highlights from Liquid Products, Volume Three include:practical details invo
Download or read book Books Out Loud written by and published by . This book was released on 2007 with total page 3214 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places
Download or read book Writing In House Medical Device Software in Compliance with EU UK and US Regulations written by Philip S. Cosgriff and published by CRC Press. This book was released on 2024-03-26 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice
Download or read book Good Laboratory Practice for Nonclinical Studies written by Graham P. Bunn and published by CRC Press. This book was released on 2022-12-13 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements
Download or read book The Software Encyclopedia written by and published by . This book was released on 1986 with total page 1744 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
