Pharmaceutical And Medical Device Compliance Manual
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Pharmaceutical And Medical Device Compliance Manual
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Author : Ela Bochenek
language : en
Publisher:
Release Date : 2019
Pharmaceutical And Medical Device Compliance Manual written by Ela Bochenek and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Drugs categories.
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
Ahla Pharmaceutical And Medical Device Compliance Manual Ahla Members
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Author : American Health Lawyers Association
language : en
Publisher:
Release Date : 2019
Ahla Pharmaceutical And Medical Device Compliance Manual Ahla Members written by American Health Lawyers Association and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with categories.
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 organizationsCompliance 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.
Compliance Handbook For Pharmaceuticals Medical Devices And Biologics
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Author : Carmen Medina
language : en
Publisher: CRC Press
Release Date : 2003-12-09
Compliance Handbook For Pharmaceuticals Medical Devices And Biologics written by Carmen Medina and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-12-09 with Medical categories.
This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Handbook Of Medical Device Regulatory Affairs In Asia
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Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2013-03-27
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-27 with Medical categories.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Medical Regulatory Affairs
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Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2022-01-27
Medical Regulatory Affairs written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-27 with Medical categories.
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Medical Device Regulations
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Author : Aakash Deep
language : en
Publisher: Academic Press
Release Date : 2022-01-13
Medical Device Regulations written by Aakash Deep and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-13 with Technology & Engineering categories.
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Data Integrity In Pharmaceutical And Medical Devices Regulation Operations
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Author : Orlando Lopez
language : en
Publisher: CRC Press
Release Date : 2016-11-03
Data Integrity In Pharmaceutical And Medical Devices Regulation Operations written by Orlando Lopez and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-03 with Business & Economics categories.
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.
Validation Standard Operating Procedures
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Author : Syed Imtiaz Haider
language : en
Publisher: CRC Press
Release Date : 2006-05-30
Validation Standard Operating Procedures written by Syed Imtiaz Haider and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-05-30 with Medical categories.
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
The Gmp Handbook
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Author : Brendan Cooper
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-07-17
The Gmp Handbook written by Brendan Cooper and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-17 with categories.
CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.
Medical Product Regulatory Affairs
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Author : John J. Tobin
language : en
Publisher: John Wiley & Sons
Release Date : 2023-08-29
Medical Product Regulatory Affairs written by John J. Tobin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-29 with Science categories.
Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
