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Risky Business: Managing the Quality of America's Medicines

Robert Rhoades

ISBN 10: 1600040136 / ISBN 13: 9781600040139
Published by FDAnews, 2008
Condition: Collectible: Like New Soft cover
From books4u31 (Asheville, NC, U.S.A.)

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Bibliographic Details

Title: Risky Business: Managing the Quality of ...

Publisher: FDAnews

Publication Date: 2008

Binding: Paperback

Book Condition:Collectible: Like New

About this title

Synopsis:

The latest edition of Risky Business: Managing the Quality of America's Medicines focuses on the human elements that influence 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.

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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