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21 Cfr Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

In the FDA regulated environment, it is not acceptable for programmers or their managers to deviate from standardized methodologies. Given the type of software commonly found in FDA regulated operations, the criticality and complexity of computer systems, the evolving regulatory climate, and the current industry best practices, validating computer systems can be problematic. Covering regulatory requirements stipulated by FDA and GAMP guidelines, 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. Whether you need to validate computer systems for pharmaceutical cosmetic, food, or medical devise applications, this book is indispensable. Discussing the regulatory requirements that are the foundation for any project, the book introduces a model that can be used to determine the Part 11 requirements for consideration during implementation. The book establishes a top-down approach to the integration of computer systems validation strategies in support of a computer systems validation project. It focuses on practical issues in computer systems implementation and operational life project management, including relevant activities to comply with Part 11, validation planning, and scheduling. The book reviews documentation in relation to CSV and procedural controls in regulated operations. The book shows how to enable compliance with computer systems validation requirements while highlighting and integrating Part 11 requirements into the entire computer validation program. The author places regulatory compliance within the context of quality assurance and emphasizes the importance of integrating validation into the system life cycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance.

Handbook of Food Factory Design

Food manufacturing has evolved over the centuries from kitchen industries to modern, sophisticated production operations. A typical food factory includes the food processing and packaging lines, the buildings and exterior landscaping, and the utility-supply and waste-treatment facilities. As a single individual is unlikely to possess all the necessary skills required to facilitate the design, the task will undoubtedly be undertaken by an interdisciplinary team employing a holistic approach based on a knowledge of the natural and biological sciences, most engineering disciplines, and relevant legislation. In addition, every successful project requires a competent project manager to ensure that all tasks are completed on time and within budget. 

This Handbook attempts to compress comprehensive, up-to-date coverage of these areas into a single volume. It is hoped that it will prove to be of value across the food-manufacturing community. The multi-disciplinary nature of the subject matter should facilitate more informed communication between individual specialists on the team. It should also provide useful background information on food factory design for a wider range of professionals with a more peripheral interest in the subject: for example, process plant suppliers, contractors, HSE specialists, retailers, consultants, and financial institutions. Finally, it is hoped that it will also prove to be a valuable reference for students and instructors in the areas of food technology, chemical engineering, and mechanical engineering, in particular.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

This book describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world. 

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low and middle income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. 
Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. 

Acronyms and Abbreviations
Front Matter
1 Introduction
2 Core Elements of Regulatory Systems
3 Critical Issues
4 A Strategy to Building Food and Medical Product Regulatory Systems
5 International Action
6 Domestic Action
7 Conclusions and Priorities

Appendix A Glossary
Appendix В A Review of Tort Liability's Role in Food and Medical Product Regulation
Appendix С Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China
Appendix D Chinese Food Regulatory System
Appendix E Meeting Agendas
Appendix F Committee Member Biographies
Appendix G Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed
Appendix H Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration

Handbook of Medical Device Regulatory Affairs in Asia

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.