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Laboratory Audits

Laboratory Audits. Version 6.0, August 2012. Objectives. 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

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Laboratory Audits

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  1. Laboratory Audits Version 6.0, August 2012

  2. Objectives • 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

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

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

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

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

  7. What is an Audit?

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

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

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

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

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

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

  14. Basic Questions

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

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

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

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

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

  20. Designate a staff member to accompany the auditor at all times. Tips 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. Make copies and label documents appropriately.

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

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

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

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

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

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

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

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

  29. Wrap Up

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