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Session Topic: 4E, Pharmaceutical Metrology

   

Paper Title: Bullet Proofing Your Calibration Program - Calibration Audits

   

Date & Time: TUESDAY, August 6, 2002

 

10:45am - 12:15pm PARALLEL SESSIONS - SESSION 4

   

Speaker: Todd McCulloch Pharmaceutical Calibrations & Instrumentation, LLC

Email: tmcculloch@pci-llc.com

   

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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