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Using Risk to Guide Implementation of Quality System Elements

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Risk is always present in every human endeavor. Managing risk to the quality of pharmaceutical products which translates to risk to the patient is the main concern of cGMP. The presentation will discuss the concept of risk levels and then identify quality system elements as identified by ICH 10 and how these are used to manage and mitigate the risk to the quality of the products.

We will discuss:

  • Quality System Elements and the risk mitigation processes
  • Implementation of process and product risk mitigation through the quality system elements Implementation of process and product risk mitigation through the quality system elements
  • How process performance and product quality improvement are achieved by implementing the Quality System Elements.

Speakers

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