BASICS OF RISK MANAGEMENT
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This book gives an insight on the risk management approach initiated by regulatory agencies with recognized management tools along with support of statistical tools are implemented across the industry. Risk Management is a systematic process for the assessment, control, communication and review of risks.
A Risk Management Program starts with identifying the possible risks associated with a product or with the process used to develop, manufacture, and distribute the product. An effective quality risk management process ensures the high quality of drug product to the patient. In addition, quality risk management improves decision making if a quality problem arises.
