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How to Develop an FDA Compliance Policy

Assume that you are the legal director for Acme and the CEO has asked you to formulate a policy to avoid a repeat in United States v. Park of the situation?

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The policy that will prevent a repeat of the United States v. Park situation will proceed as follows: All FDA regulations will be made a component of the organization's standard operations procedures manual. In addition, the CEO and all management staff will be trained in the legal components of the FDA regulations that apply to their organization, and after this ...

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This solution describes the development of aspects of an FDA compliance policy.