Firms Report Mixed Experiences In Hosting AP Training Inspections

A THIRD-PARTY TRAINING INSPECTION at a Philips Medical Systems plant in Germany resulted in a warning letter, to the firm’s surprise. Philips volunteered for the audit in order to support FDA’s Accredited Persons inspection program, which is languishing due to difficulties in scheduling training sessions for the participating third-party auditors. A Philips exec describes what happened at this inspection and a separate, more successful AP training session in Andover, Mass., while a Gambro manager details a training audit at her firm that went well. Only nine out of 55 third-party auditors have completed the training necessary to perform independent FDA inspections