Within his thirty-seven year career, Mr. Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives regarding 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.
Mr. Rhoades is often engaged to provide post-Warning-Letter guidance and remediation project management to re-establish client credibility with the FDA, as well as assisting manufacturers in proactively designing quality systems to assure successful inspections. Mr. Rhoades has also worked in concert with client counsel on a wide variety of legal cases. He was selected by client counsel to advise in the contaminated heparin crisis that reached world-wide proportions in 2008. His first book, Risky Business: Managing The Quality of America’s Medicines, was released in February 2004 by FDANews, and is now in its second edition.