Risky Business: Managing the Quality of America’s Medicines focuses on the human elements — how quality processes happen and how people figure into that equation in both design and execution. Written from the perspective of a 30-year veteran of quality management, Robert Rhoades understands the challenges FDA-regulated industries face. He thoroughly explores the world of quality control and focuses on common problem areas.

This valuable publication covers:

• Common challenges that surface when encouraging a culture of quality compliance
• Real-life and fictionalized anecdotes that highlight the underpinnings of FDA quality regulations
• Resources to help quality professionals encourage and improve performance in an area that’s so often neglected
• Insights into an FDA inspector’s approach to evaluating quality

You’ll have an understanding of how to overcome the many obstacles that arise when incorporating and maintaining quality control in a corporation.

Key chapters in Risky Business: Managing the Quality of America’s Medicines include:

• Strange Bedfellows — Science, Business, Politics and the Law
• Pharmaceutical Quality Control — Today’s State of the Art
• 25 Years of Regulation — And Still Failing
• The Quality Assurance Function: A Small Force in a Large Battle
• Money and Morals — Management Responsibility in the Pharmaceutical Industry
• Drug Regulation Today — Limitations of the FDA
• The Patient Is Waiting — Quality’s Quiet Impact on the Public Trust
• Targets for Managers — Some Points to Consider

Plus:

• Notes and Sources
• Appendix: The Seventh System Field Guide
• Resources for Pharmaceutical Quality Managers

Order now and get the information you need to prevent quality deficiencies in your organization.

About the Author
Robert A. Rhoades is a 30-year veteran of quality management in FDA-regulated industry. A graduate of Purdue University and Lake Forest Graduate School of Management, his combination of technical training and business experience lend a unique perspective to the complex world of pharmaceutical manufacturing, marketing and law. His experience spans the quality discipline from managing the quality function at Baxter and Bausch & Lomb, to serving as quality advisor to the CEO at Solvay Pharmaceuticals, to planning and implementing quality management and performance-improvement systems for client companies. Mr. Rhoades has guided foreign firms through the development and implementation of quality systems that achieved zero-deficiency preapproval inspections. He has also led numerous compliance-related projects in the form of due diligence reviews for acquisition targets, the redesign of quality functions and the development of complex corrective action plans that averted escalation of enforcement actions by the FDA. He has worked in concert with client counsel on a wide variety of legal cases and high-profile public cases, such as the heparin crisis of 2008. He is currently director of the Pharmaceutical Quality and Compliance Practice for Becker & Associates, a Washington, D.C.-based consulting firm.

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Here’s What Readers of Risky Business: Managing the Quality of America’s Medicines Have to Say
 “I found this book to be a must, no, make that a required read for those in the medical products manufacturing community. In my 36 years with the FDA, I found the author to tell it like it is on managing quality. Robert does an excellent job of showing how quality is interwoven throughout a company and how important change control is to ensure quality. The book clearly demonstrates that very bad things will happen when quality is not 100%. I am eagerly awaiting the next edition of the book.”
Robert C. Coleman
FDA Investigator and National Drug Expert, Retired

“Every individual employee in the pharmaceutical industry must be fully dedicated to compliance — it’s not only our license to be in business, it has to be our mindset and culture that we altogether owe to our families, friends, neighbors, societies and ourselves. Compliance is an integral part of quality manufacturing, demanding fact- and science-based decisions and the will to execute accordingly. This book is a thriller and must-read for all organizational levels raising understanding and acceptance for compliance.”
Andreas Winterfeldt
Corporate Senior Vice President, Head of Corporate Division — Chemicals
Boehringer Ingelheim

“ Bob’s experiences and lessons learned form the basis for a valuable message about the need for effective quality management. Hopefully, readers of Risky Business will be stimulated to re-consider the effectiveness of the processes and systems that comprise quality management in their company. Never before has it been more important to use sound science in a company’s quest to develop and manufacture profitable drugs that are safe and effective.”
Dr. Ron Tetzlaff
Corporate Vice President, PAREXEL Consulting,
and Former FDA National Expert