The last few years have presented extraordinary regulatory and quality compliance challenges for pharmaceutical, biotechnology, and medical device companies charged to do more with less as a result of consolidation, restructuring, and economic uncertainty. Without the right attention, these challenges can permit systems and processes to weaken, domain and critical thinking expertise to erode, and core quality principles to be neglected, leaving companies vulnerable to compliance lapses and enforcement action.

Companies can no longer afford to take a traditional compliance approach in this heightened regulatory environment. In the traditional compliance approach, Quality Assurance and Compliance are backroom cost centers, the internal police or “sales prevention” departments perceived as piling on non-value added requirements that detract from the company’s ability to innovate and be profitable.

About the Author

Robert A. Rhoades is Practice Leader, Quality Systems at Quintiles Consulting. For 32 years he has held positions in Quality for FDA-regulated industries advising senior pharmaceutical and medical device executives on compliance and its impact on corporate direction and strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for major manufacturers in the US, Europe, China and India.

His first book, Risky Business: Managing The Quality of America’s Medicines, was released in February 2004 by FDA News, and is now in its second edition. A second book, Sustaining Compliance: Strategies for Maintaining Drug Quality, was released in July 2005.