Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News

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Terri P. Kelly, RN, MSQA, CQA President and Principal ... - FDA News

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SOP Format<br />

� Header<br />

� Purpose<br />

� Scope<br />

� Definitions<br />

� Responsibility<br />

� Procedure Steps<br />

� Revision History<br />

� References

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SOP Format � Header � Purpose � Scope � Definitions � Responsibility � Procedure Steps � Revision History � References

Page 1 and 2: Terri P. Kelly, RN, MSQA, CQA Presi
Page 3: Procedural Documents
Page 7 and 8: Scope �Range, capacity, extent
Page 9 and 10: Responsibility �Can be combined w
Page 11 and 12: Revision History �New SOP: N/A
Page 13 and 14: Expectations During Sponsor / CRO I
Page 15 and 16: Sponsor/CRO Clinical Operations �
Page 17 and 18: Sponsor Warning Letters •[21 CFR
Page 19 and 20: Sponsor Warning Letters •[21 CFR
Page 21 and 22: Clinical Investigator SOPs � Inve
Page 23 and 24: CI Warning Letters • [21 CFR 312.
Page 26: Thank you! Terri P. Kelly, RN, MSQA