Development of FDA-Regulated Medical Products - Prescription Drugs, Biologics, and Medical Devices

Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. This revised edition includes: updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. The author also covers the Food and Drug Administration’s Modernization Act (FDAMA), along with discussions on intellectual property, pharmacoeconomics, and technological and medical trends. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices industry. Helpful references include a glossary, acronyms, and a list of useful resources. Content: Front Matter • List of Figures and Tables Prefaces • Abbreviations • Table of Contents •Part I. Unique Challenges in Medical Product Development• 1. Healthcare in the United States 2. It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation 3. Product Liability and Product Development •Part II. Bringing a New Medical Product to Market 4. Overview of the Approval Processes for Drugs, Biologics, and Medical Devices • 5. Designing-in Quality 6. Designing-out Disaster: Risk Analysis 7. Recalls, Revocations, and Withdrawals • 8. Human Factors and the Nature of Relationships: Minimizing Medical Errors 9. Is it Safe and Does it Work?: Evaluating Safety and Efficacy in Clinical Trials 10. How Much is the Product Really Worth?: Outcomes Research, Pharmacoeconomics, and Managed Care •Part III. Product Development Planning 11. Models and Metaphors: Product Development and the Product Development Organization 12. Components of Product Development Planning: The Product Development Process 13. Components of Product Development Planning: Development Portfolio Management • 14. Components of Product Development Planning: Technology Assessment • 15. Components of Product Development Planning: Technology Forecasting 16. More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality 17. Where Do We Go from Here? • Endnotes • Glossary • Resources Index There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. The revised book a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources. After reading this book, individuals involved in medical product development, regardless of their background or functional discipline, will understand all facets of the processfrom idea creation through to commercialization and marketing. Welcome to auditing Getting the assignment Audit process inputs (purpose and scope) Preparing for the audit Identifying requirements and planning Desk audit and audit strategies Beginning the audit Data collection Techniques to improve effectiveness and address vague requirements Analyzing the results Reporting Audit follow-up, corrective action, and closure Appendix A Example audit plan Appendix B Example work order Appendix C Example meeting agenda and record Appendix D Example interview schedule Appendix E Example checklist page Appendix F Audit time considerations Appendix G Example notification letter Appendix H Popular performance standards Appendix I Example audit report Appendix J Auditor code of conduct Appendix K Example corrective/preventive action request Appendix L Corrective action checklist Appendix M 20 basic audit principles Glossary Recommended references Index. This best-seller prepares auditors to conduct internal audits against quality, environmental, safety, and other audit criteria. This handy pocket guide covers all the steps necessary to complete an internal audit, from assignment to follow-up. New and updated chapters reflect new techniques to address vague requirements, more illustrations and examples, ISO 19011 thinking, and verification of auditee follow-up actions. This condensed, easy-to-read book is a valuable resource and great tool for training others on how to perform an internal audit. It is appropriate for those who have no prior knowledge of audit principles or techniques. This best-seller pocket guide prepares auditors to conduct internal audits against quality, environmental, safety, and other audit criteria. This handy pocket guide covers all the steps necessary to complete an internal audit, from assignment to follow-up. New and updated chapters reflect new techniques to address vague requirements, more illustrations and examples, ISO 19011 thinking, and verification of auditee follow-up actions. This condensed, easy-to-read book is a valuable resource and great tool for training others on how to perform an internal audit. It is appropriate for those who hav

this Best-seller Is Fully Updated And Expanded! The Entire Audit Process Is Discussed, From The Audit Assignment To Analyzing Results And Following Up On The Action Items. This Easy-to-use Pocket Guide Summarizes All The Steps Necessary To Complete An Internal Audit. New And Updated Sections Reflect New Techniques, Iso 19011 Thinking, And The Approach To New Standards. The Condensed Format Of This Book Makes It A Good Tool To Use When Training Others How To Perform An Internal Audit And Is Appropriate For Those Who Have No Prior Knowledge Of Audit Principles Or Techniques.

Provides basic information on how to conduct an internal audit presented in pocket-sized format. Includes examples and templates