0 Risk Management Basics

--> a risk management framework for product development, routine operations, and commercial distribution activities that is anchored in the product safety imperatives of the market and the patient. --> an approach to the investigation of OOS results, deviations, complaints and study failures that protects the technical, trouble-shooting environment required to solve real problems, prevents potential problems, and preserves the business values and priorities of the organization. -->a triage system for information monitoring programs and deviation investigations based on risk to product safety that conserves organizational resources. -->examples of why things go wrong in high technology industries and how accidents-of-management can compromise corporate profit and product safety. -->a new approach to organizational design that supports a product focused quality system and protects the productive core of the corporation from problems and inefficiencies.

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