Bob Rhoades Email & Phone Number

Throughout his 45-year career, Mr. Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives seeking counsel on compliance and its impact on corporate direction and business strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for manufacturers in the US, Europe, India and China. He frequently provides post-Warning-Letter guidance and remediation project management to re-establish client credibility with the FDA. In addition, he assists manufacturers in proactively designing and optimizing quality systems. Mr. Rhoades often works 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 global proportions in 2008, and has provided third-party expert services in several Consent Decree cases.Specialties: cGMP compliance for all FDA-regulated products, world-wide:21 CFR 210, 211,21 CFR 820, ICH Q8, ICH Q9, ICH Q10ICH Q7A.

Listed skills include Project Management, Crisis, Services, Fda, and 3 others.