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New Book Prescribes Quality Guidance for Pharma Industry as Criticism of FDA and Consumer Safety Concerns Surge

WASHINGTON, Feb. 2 /PRNewswire/ -- Risky Business: Managing the Quality of America's Medicines has been released in its Second Edition by FDAnews. Authored by Robert A. Rhoades, Practice Director, Pharmaceutical Quality & Compliance at Becker & Associates Consulting (Washington, DC), the book offers insights from more than 30 years in the industry. The update for the Second Edition is timely in light of significant events in the industry throughout 2008. With a new administration, an embattled FDA under scrutiny from Congress, and an industry under fire for insufficient controls in the supply chain from foreign manufacturing sites, Mr. Rhoades provides clear and actionable guidance for executives responsible for risk management, both here and abroad.

Laurence Downey, MD, retired President and CEO of Solvay Pharmaceuticals, says in the book's foreword: "One deliverable that should be assured for all of our customers is the quality of our products. The future credibility and reputation of our industry, already compromised, is at stake ... This book offers a hard-hitting message to help us avoid the temptation to cut corners and so keep our companies off the front-page -- at least for the wrong reasons. After all, this industry is about putting patients first."

"We are at the start of a hyper-vigilant period when it comes to the inspection and enforcement of quality systems both nationally and internationally," said Ron Ginor, MD, president of Becker & Associates Consulting in Washington, DC. "Given recent events, consumers and regulators have little tolerance for system failures, and corporations will have to proactively redouble their efforts in order to protect their consumers and their reputation in this context."

The book is available now through FDAnews at, and at

About Becker & Associates Consulting, Inc.

Becker & Associates Consulting, Inc. is a strategic consulting firm specializing in clinical, regulatory, and compliance issues. Based in Washington DC, the firm provides sophisticated consulting skills, unique scientific and business experience, and excellent relationships with regulators, subject matter experts, counsel, and policy leaders to support the development and stewardship of innovative healthcare products.

SOURCE Becker & Associates Consulting, Inc.
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