Inspection/Audit Plan to Prepare Site for an FDA Inspection
To prepare an audit/inspection plan that will help to ensure that your mock company, a new drug product sponsor, is using clinical site that will comply with GCP requirements as they contribute to the development and testing of your new drug product for human use. As a Regulatory Affairs representative, you will likely be asked to assist in the assessment of clinical site that will be used for research project sponsored by your company. You are to write a project plan that describes activities that are needed to prepare for, implement, and summarize a regulatory inspection of a clinical site that is conducting clinical studies under the GCP regulations.
This paper requires you to prepare an audit/inspection plan for:
Ø The Clinical site where the test article( Drug) will be tested in human subjects;
NOTE: Detailed Instructions/ References/template Attached
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