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Session Topic: 4E, Pharmaceutical Metrology |
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Paper Title: Bullet Proofing Your Calibration Program - Calibration Audits |
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Date & Time: TUESDAY, August 6, 2002 |
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10:45am - 12:15pm PARALLEL SESSIONS - SESSION 4 |
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Speaker: Todd McCulloch
Pharmaceutical Calibrations & Instrumentation, LLC |
Email: tmcculloch@pci-llc.com |
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Audits from customers or the FDA are looking for faults within a calibration program. This session includes an in-depth explanation of the steps required for successful calibration audits. This session details discussions of procedures, calibration reporting, and equipment files and how they relate to audits. Examples of FDA 483’s and warning letters pertaining to calibration audits will be presented. This session also addresses:
1. Writing calibration reports and deviation reports;
2. Scheduling and tracking calibrations; and
3. Ensuring documentation is cGMP compliant. |
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