Pharmaceutical and Medical Device Compliance Manual
Pharmaceutical and Medical Device Compliance Manual

Author: Ela Bochenek

Publisher:

Published: 2019

Total Pages: 319

ISBN-13: 9781522178026

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A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Author: Orlando Lopez

Publisher: Taylor & Francis

Published: 2018-10-02

Total Pages: 232

ISBN-13: 1351704346

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Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Pharmaceutical Manufacturing Handbook
Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-03-11

Total Pages: 1386

ISBN-13: 0470259809

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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Compliance in the Pharmaceutical Industry
Compliance in the Pharmaceutical Industry

Author: Cybellium

Publisher: Cybellium Ltd

Published:

Total Pages: 229

ISBN-13: 1836796269

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Welcome to the forefront of knowledge with Cybellium, your trusted partner in mastering the cutting-edge fields of IT, Artificial Intelligence, Cyber Security, Business, Economics and Science. Designed for professionals, students, and enthusiasts alike, our comprehensive books empower you to stay ahead in a rapidly evolving digital world. * Expert Insights: Our books provide deep, actionable insights that bridge the gap between theory and practical application. * Up-to-Date Content: Stay current with the latest advancements, trends, and best practices in IT, Al, Cybersecurity, Business, Economics and Science. Each guide is regularly updated to reflect the newest developments and challenges. * Comprehensive Coverage: Whether you're a beginner or an advanced learner, Cybellium books cover a wide range of topics, from foundational principles to specialized knowledge, tailored to your level of expertise. Become part of a global network of learners and professionals who trust Cybellium to guide their educational journey. www.cybellium.com

FDA Establishment Inspections
FDA Establishment Inspections

Author: Mindy J. Allport-Settle

Publisher: Pharmalogika

Published: 2010-06-30

Total Pages: 358

ISBN-13: 9780982147665

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Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.

Pharmaceutical Manufacturing Handbook
Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-04-04

Total Pages: 857

ISBN-13: 0470259825

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With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

Author: Graham P. Bunn

Publisher: CRC Press

Published: 2019-02-04

Total Pages: 387

ISBN-13: 1498732070

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This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Environmental Investigation and Remediation
Environmental Investigation and Remediation

Author: Thomas K.G. Mohr

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 552

ISBN-13: 0203489373

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A ubiquitous, largely overlooked groundwater contaminant, 1,4-dioxane escaped notice by almost everyone until the late 1990s. While some dismissed 1,4-dioxane because it was not regulated, others were concerned and required testing and remediation at sites they oversaw. Drawing years of 1,4-dioxane research into a convenient resource, Environmental

Data Integrity and Data Governance
Data Integrity and Data Governance

Author: R. D. McDowall

Publisher: Royal Society of Chemistry

Published: 2018-11-09

Total Pages: 660

ISBN-13: 178801281X

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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.

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Author: Orlando Lopez

Publisher: CRC Press

Published: 2015-04-06

Total Pages: 262

ISBN-13: 1040083706

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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