1. This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS). Laboratory Audits Version 6.0, August 2012

2.  Define an audit and list four different types of audits  List the types of audits associated with the Food and Drug Administration (FDA), Accreditation/Certification Body and Sponsor  List and explain the steps involved in conducting a Division of Acquired Immunodeficiency Syndrome (DAIDS) audit  Describe how to manage and prepare for an audit Objectives 2

3. Do auditors always provide advance notice prior to audit visits? A.Yes B.No Pre-Assessment Question #1 3

4. Audits by College of American Pathologists (CAP) would be considered: A.Regulatory audits B.Accrediting body audits C.Internal audits D.Sponsor audits Pre-Assessment Question #2 4

5. Which of the following is not a typical step in the DAIDS audit process? A.Send pre-visit letter and audit checklist 5 days prior to the audit B.Conduct an opening meeting to review audit agenda C.Visit the laboratory and observe operational procedures D.Debrief the laboratory on audit findings Pre-Assessment Question #3 5

6. In preparation for an FDA audit, laboratory staff should: A.Designate a staff member to accompany the auditor at all times B.Review the audit agenda to determine the scope C.Notify DAIDS and clinic staff D.Make copies and label documents appropriately E.All of the above Pre-Assessment Question #4 6

7. 7 What is an Audit?

8. An examination of records to check their accuracy The act of assessing; appraisal The act of inspecting; official examination or review An examination of records to check their accuracy Audit Assessment Inspection Definitions 8

9. Types of Audits Regulatory Audits Accrediting Body Audits Internal Audits Sponsor Audits 9

10. For-Cause Audit Targeted Audit Whistle Blower Unpredictable Frequency Guidelines FDA FDA Audits 10

11. Accreditation/Certification Body Audits Accreditation Requirements Certification Requirements Possible Advanced Notice Guidelines Available Online Accreditation/ Certification Body 11

12. Sponsor Audits Facility Operation Check for GCLP Compliance Scheduling Flexibility Advanced Notice Guidelines Sponsor 12

13. Sponsor Audits (cont’d) 2. Schedule Visit 3. Send Pre Visit Letter (PVL) 4. Opening Meeting 5. Gather Evidence 6. Record Findings 7. Debrief 8. Audit Report Conducting the Audit 1. Receive Request 13

14. What is done? Who is doing what? How is it done? Why is it done? When is it done? Where is it done? Basic Questions 14

15. What Steps Should You Take When You Are Notified of an Audit? 15

16. Notify All Appropriate Persons FDA Audit DAIDS Laboratory Staff Other Staff 16

17.  Most agencies will give advanced notice  If an agenda is provided, review it, and plan carefully Determine the Scope 17

18. Be Prepared! Once an audit is scheduled, you will already be prepared… RIGHT? But, what does that mean? 18

19. Unpredictable Approximately two days FDA Audit Accrediting Agency Audit Sponsor Audit Length of Audit 19

20. Tips Make copies and label documents appropriately. Designate a staff member to accompany theauditor at all times. Create a file for the audit and make a duplicate copy for your file. Answer the auditor’s queries with clear, concise answers. Don’t over do it. 20

21. Tips (cont’d) Make sure you understand what the auditor is requesting. Ask follow-up questions. Example: “Is that whatyou were looking for?” Present questions to the auditor and clarify otherissues raised. Insist on a debriefing or summation. 21

22. The Audit Report Laboratory Audit Report Have I reviewed it carefully? Is it accurate? 22

23. Audits What are the negatives? What are the positives? 23

24. Do auditors always provide advance notice prior to audit visits? A.Yes B.No Post-Assessment Question #1 24

25. Audits by CAP would be considered: A.Regulatory audits B.Accrediting body audits C.Internal audits D.Sponsor audits Post-Assessment Question #2 25

26. Which of the following is not a typical step in the DAIDS audit process? A.Send pre-visit letter and audit checklist 5 days prior to the audit B.Conduct an opening meeting to review audit agenda C.Visit the laboratory and observe operational procedures D.Debrief the laboratory on audit findings Post-Assessment Question #3 26

27. In preparation for an FDA audit, laboratory staff should: A.Designate a staff member to accompany the auditor at all times B.Review the audit agenda to determine the scope C.Notify DAIDS and clinic staff D.Make copies and label documents appropriately E.All of the above Post-Assessment Question #4 27

28.  DAIDS Laboratory Audit Process  Introduction to the US FDA Inspection Process  (DAIDS LMS course 1230) https://daidslms.plateau.com/learning/user/login References/Resources 28

29. Wrap Up 29