Get It Right is based on the trials and tribulations seen by the author in nearly 30 years of experience at a wide variety of companies. This book describes real-life solutions and is intended to provide a unique but straightforward approach to business and regulatory requirements. It will be useful both for beginners looking for a road map and also experienced professionals searching for effective ways to continuously improve their quality systems. Examples used throughout the book are based on actual companies and experiences.
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Ken Imler is currently a Quality and Regulatory consultant at Quintiles Consulting, where he has consulted at a variety of companies (drugs, devices, biologics and combination products) for the past seven years. He helped design, reengineer and implement several effective quality systems, and assisted companies in both strategic and tactical aspects of Quality Systems. He has a BS from the University of California, an MT (ASCP) from St. Joseph s Hospital School of MT, and an MBA National University.
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