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 AuditsVersion 6.0, August 2012
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
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3
Do auditors always provide advance notice prior to audit visits?
A. YesB. No
Pre-Assessment Question #1
4
Audits by College of American Pathologists (CAP) would be considered:
A. Regulatory auditsB. Accrediting body auditsC. Internal auditsD. Sponsor audits
Pre-Assessment Question #2
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 agendaC. Visit the laboratory and observe operational proceduresD. Debrief the laboratory on audit findings
Pre-Assessment Question #3
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 scopeC. Notify DAIDS and clinic staffD. Make copies and label documents appropriatelyE. All of the above
Pre-Assessment Question #4
7
What is an Audit?
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
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Types of Audits
Regulatory Audits
Accrediting Body Audits
Internal Audits
Sponsor Audits
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For-Cause Audit
Targeted Audit
Whistle Blower
Unpredictable Frequency
Guidelines
FDA
FDA Audits
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Accreditation/Certification Body Audits
Accreditation Requirements
Certification Requirements
Possible Advanced Notice
Guidelines Available Online
Accreditation/Certification
Body
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Sponsor Audits
Facility Operation
Check for GCLP Compliance
Scheduling Flexibility
Advanced Notice
Guidelines
Sponsor
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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 Audit1. Receive Request
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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
What Steps Should You Take When You Are Notified of an Audit?
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Notify All Appropriate Persons
FDA Audit
DAIDS
Laboratory Staff
Other Staff
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Most agencies will give advanced notice
If an agenda is provided, review it, and plan carefully
Determine the Scope
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Be Prepared!
Once an audit is scheduled, you will already be prepared…
RIGHT?
But, what does that mean?
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Unpredictable
Approximately two days
Approximately two days
FDA Audit
Accrediting Agency Audit
Sponsor Audit
Length of Audit
19
Tips
Make copies and label documents appropriately.
Designate a staff member to accompany the auditor 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.
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Tips (cont’d)
Make sure you understand what the auditor is requesting.
Ask follow-up questions. Example: “Is that what you were looking for?”
Present questions to the auditor and clarify other issues raised.
Insist on a debriefing or summation.
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The Audit Report
LaboratoryAudit Report
Have I reviewed it carefully?
Is it accurate?
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Audits
What are the negatives?
What are the positives?
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Do auditors always provide advance notice prior to audit visits?
A. YesB. No
Post-Assessment Question #1
25
Audits by CAP would be considered:
A. Regulatory auditsB. Accrediting body auditsC. Internal auditsD. Sponsor audits
Post-Assessment Question #2
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 agendaC. Visit the laboratory and observe operational proceduresD. Debrief the laboratory on audit findings
Post-Assessment Question #3
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 scopeC. Notify DAIDS and clinic staffD. Make copies and label documents appropriatelyE. All of the above
Post-Assessment Question #4
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DAIDS Laboratory Audit Process
Introduction to the US FDA Inspection Process (DAIDS LMS course 1230)
https://daidslms.plateau.com/learning/user/login
References/Resources
Wrap Up
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