CSA and CAPAs: Two Products of Risk Management

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CSA and CAPAs: Two Products of Risk Management

Daniel Walter

Policy Analyst, Compliance and Quality Staff

FDA

Profile

CDRH has promoted two of Case for Quality projects, Make CAPA Cool and Computer Software Assurance, as examples of focusing on business practices. The key point in both projects is the growing focus on risk, which is a pivotal component in decision making for all parties in life science product manufacturing. We will discuss FDA’s considerations and progress on these topics and discuss related questions and concerns.

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