Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News
Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News
Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News
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Expectations During<br />
Sponsor / CRO Inspection<br />
� Table of Contents<br />
� Corporate Level SOPs<br />
� Controlled Documents<br />
� Training<br />
� Suspected Misconduct <strong>and</strong> Serious Breach Mgt<br />
� Corrective <strong>and</strong> Preventative Action<br />
� System Access <strong>and</strong> Part 11 Compliance<br />
� Document Retention / Archival<br />
� Facility Security<br />
� Disaster Recovery <strong>and</strong> Business Continuity<br />
� Vendor Management<br />
� Department Level SOPs
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