4-Day Training Workshop
August 6 @ 9:00 AM – August 9 @ 5:00 PM
This rigorous four-day program is ideal for those who are looking for an in-depth, hands-on introduction to conducting laboratory audits. Participants will come away with a basic understanding of audit principles and process with audit planning, conduct, report preparing, and closeout. Portions of the course will be hands-on in the lab where we review various laboratory equipment and documentation to simulate an actual lab audit. Attendees will work through each step of the audit process as a team. The risk-based approach to auditing will be discussed as well as key highlights surrounding regulatory inspection preparedness. This workshop is ideal for lab staff, QC, QA, and other operations staff interested in moving into or responsible for auditing.
Overview of Workshop:
Day 1
- Background of Auditing.
- Routine vs. For Cause Audits.
- Auditing Strategies/Techniques (why audit).
- Preparation for Auditing a Lab.
- Preparing a Lab Audit Plan.
- Preparing a Lab Audit Checklist.
Day 2
- Simulating the Opening Meeting of a Lab Audit.
- Conducting Interviews in a Lab Audit.
- How to Review Objective Evidence and What to Look For.
Day 3
- Simulating the Closing Meeting for a Lab Audit.
- Preparing a Lab Audit Report.
- Finding vs Recommendations, What is the Difference.
Day 4
- Resolution of Audit Findings.
- How to Close Out an Audit.
- When to Reaudit?