Compliance Handbook For Pharmaceuticals Medical Devices And Biologics PDF Download
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Author | : Carmen Medina |
Publisher | : CRC Press |
Total Pages | : 604 |
Release | : 2003-12-09 |
Genre | : Medical |
ISBN | : 0824758749 |
Download Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics Book in PDF, ePub and Kindle
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.
Author | : Ela Bochenek |
Publisher | : |
Total Pages | : 319 |
Release | : 2019 |
Genre | : Drugs |
ISBN | : 9781522178026 |
Download Pharmaceutical and Medical Device Compliance Manual Book in PDF, ePub and Kindle
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
Author | : Douglas J. Pisano |
Publisher | : CRC Press |
Total Pages | : 360 |
Release | : 2003-12-23 |
Genre | : Medical |
ISBN | : 9781587160073 |
Download FDA Regulatory Affairs Book in PDF, ePub and Kindle
Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.
Author | : Jack Wong |
Publisher | : CRC Press |
Total Pages | : 806 |
Release | : 2022-01-27 |
Genre | : Medical |
ISBN | : 1000440516 |
Download Medical Regulatory Affairs Book in PDF, ePub and Kindle
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.
Author | : American Health Lawyers Association |
Publisher | : |
Total Pages | : |
Release | : 2019 |
Genre | : |
ISBN | : 9781522178040 |
Download AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members) Book in PDF, ePub and Kindle
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.
Author | : Aakash Deep |
Publisher | : Academic Press |
Total Pages | : 187 |
Release | : 2022-01-13 |
Genre | : Technology & Engineering |
ISBN | : 0323911277 |
Download Medical Device Regulations Book in PDF, ePub and Kindle
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
Author | : Elijah Wreh |
Publisher | : Elsevier |
Total Pages | : 680 |
Release | : 2023-02-22 |
Genre | : Technology & Engineering |
ISBN | : 0323953530 |
Download Medical Device Regulation Book in PDF, ePub and Kindle
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations
Author | : Brendan Cooper |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 150 |
Release | : 2017-07-17 |
Genre | : |
ISBN | : 9781548370251 |
Download The GMP Handbook Book in PDF, ePub and Kindle
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.
Author | : Smita Gopalaswamy |
Publisher | : CRC Press |
Total Pages | : 168 |
Release | : 2008-04-22 |
Genre | : Business & Economics |
ISBN | : 1040068960 |
Download Combination Products Book in PDF, ePub and Kindle
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
Author | : Sandy Weinberg |
Publisher | : John Wiley & Sons |
Total Pages | : 295 |
Release | : 2011-04-18 |
Genre | : Medical |
ISBN | : 111800227X |
Download Cost-Contained Regulatory Compliance Book in PDF, ePub and Kindle
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.