The Medical Device Validation Handbook is a unique and essential compilation of the regulatory professional's role in the validation and verification processes of medical devices. Since international validation standards change with new iterations, this handbook helps you remain current on validation guidelines and quality control measures needed to comply with federal and international requirements. Each chapter is written by an expert in the field.

The Medical Device Validation Handbook

Unknown, Author

Regulatory Affairs Professionals Society (RAPS)

* Fundamentals of US Regulatory Affairs, 10th Edition available July 2017. Knowledge is the driving force of success in regulatory. Whether you are navigating the world of the US Food and Drug Administration or working in pharmaceuticals, biotech or medical devices, you need access to the most up-to-date information in your field. With new and updated content on everything from the history of food, drug and cosmetic laws to crisis management and FDA inspection and enforcement, this all-in-one reference book has you covered. The ninth edition features the experience and analysis of 49 authors in 41 chapters, and includes an updated matrix listing all pertinent laws and regulations as well as numerous tables, figures and other visual aids. It also includes three new chapters covering essentials such as regulatory strategy, stem cell technology and user fees. This new and innovative edition is the definitive guide to all US regulatory matters. RAPS and its expert authors have gathered all the information for you to continue your success and regulatory excellence.

Fundamentals of US Regulatory Affairs Ninth edition

RAPS

As you conduct your due diligence process, arm yourself with the regulatory knowledge of RAPS' expert Ray Huml and the techniques that led to over $2.7bn in capital committed to various large- and small-scale product partnering opportunities in the US and Europe. Introduction to Due Diligence Process features text covering all major aspects of the due diligence process and provides easy-to-use checklists to ensure all facets of selected functional areas of expertise are covered, including those for regulatory professionals. With this publication-based on a series originally published in RAPS' Regulatory Focus-regulatory professionals at all phases of their careers will be more capable of predicting future events, driving regulatory excellence and managing risk across the industry.

Introduction to the Due Diligence Process (With CD-ROM)

Raymond A. Huml

The promotion of FDA-regulated drugs is a complex endeavor that spans the full depth of the regulatory industry. Synthesizing the publicly available information from the US Food and Drug Administration's requirements for the promotion of these drugs, this RAPS resource helps regulatory professionals at all levels of their careers navigate these intricate regulations. With chapters focusing on everything from risk information, pharmacoeconomics and labeling to social media, this guide can be used as a reference for experienced regulator pros or an outstanding resource for anyone in prescription drug marketing.

FDA Requirements for Prescription Drug Promotion

John Driscoll

Since its launch in 1999, Fundamentals of US Regulatory Affairs has been RAPS' top selling publication-relied upon by those new to regulatory and trusted by seasoned professionals. The much anticipated international edition-Fundamentals of International Regulatory Affairs-is now available!Whether you are new to regulatory affairs, preparing for the RAC (General Scope) Exam or looking for a touch-up of the fundamentals in your field, the Fundamentals of International Regulatory Affairs, First Edition will serves as an excellent reference tool to put you on the right path in your career. This essential text provides a comprehensive understanding of established international regulatory requirements across product linesFeaturing: * International guidance documents from ICH, GHTF, WHO and ISO * Comparison of submission requirements around the world * Illustrative figures and tablesRegulatory students: Ask you professor about special RAPS pricing on the Fundamentals series.RAPS does not accept exchanges or returns on items that have already been shipped or emailed. Cancellations of orders must be made within 24 hours from the time the original order was placed.

Fundamentals of International Regulatory Affairs, Second Edition

In the fast-paced regulatory industry, it's vital to hone your research skills. This updated definitive guide features new information on due diligence and measuring RI results, plus tricks of the regulatory intelligence gathering trade that streamline your individual research process and a toolbox for setting up a regulatory intelligence department within your company.

Regulatory Intelligence 101, Second Edition

Meredith Brown-Tuttle, RAC

As globalization continues to increase, more companies are marketing products in multiple countries and regions. This book provides a "how to" guide to developing a comprehensive global regulatory strategy for all types of medical devices. Discussions cover medical device types, assembling a core development from multiple departments to create a strong, viable strategy to market a product in more than one jurisdiction, and basic strategy components. There also is information on device design and development elements, setting up a quality management system, labeling strategies and manufacturing. Other chapters look at the Notified Body's viewpoint on regulatory strategy and that of regulators. Much more information is included in the book, including the use of standards cover global regulatory processes and how patents apply to medical devices.

Global Medical Device Regulatory Strategy

This edition of Fundamentals of EU Regulatory Affairs focuses on changes to healthcare product development, manufacturing and marketing across the EU. The most significant changes since the introduction of the Medical Devices Directive are coming with the implementation of the EU Medical Device Regulation and EU In Vitro Diagnostic Device Regulation. Clinical trial regulations implementation has been delayed, but its impact is discussed. There are several new chapters in this edition, covering EMA and other EU regulatory bodies, preparing for EMA meetings, regulatory strategy, medical device preclinical testing, adaptive and alternative medicinal product pathways and more. This book is an excellent reference for anyone at any level working in regulatory affairs in the EU market and a useful tool for those planning to sit for the RAC (EU) exam.

Fundamentals of EU Regulatory Affairs, Eighth Edition

This book is a must-have for those involved in the verification and validation of medical devices for the US market. It not only updates information from the original, it includes seven new chapters. The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket. It clearly details how and why various processes and equipment must be validated and how the methodology had progressed. The new chapters discuss the need for test method validation, device test method validation, design of experiments, additive (3D printing) manufacturing, cybersecurity and data integrity, validation of the laser welding process and the set-up of cleanrooms, both initially and following a worst-case event. Updated chapters include, among others, the history of device validation and validation of design, sterilization, packaging, cleaning, software and equipme

The Medical Device Validation Handbook, Second Edition

Max Sherman

Fundamentals of EU Pharmaceutical and Biologics Regulations

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