Quality Risk Management Tools

Global Regulations and Risk Management Tools

To compete in today's global market, regulated companies must comply with numerous requirements, directives, and standards from regional, national, and international bodies. The requirements vary, but they all emphasize risk management and require the use of quality risk management tools. Whether they are regulatory requirements (FDA , WHO GMP, EU GMP) or guidelines from ICH and industry organizations (ISPE, PDA, IPEC, APIC), they all share the common goal of minimizing, if not preventing, risks to patients and consumers.

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