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AP Inspector Training Slowed By Weak Industry Support, Restrictive FDA Policies

This article was originally published in The Silver Sheet

Executive Summary

FDA’s THIRD-PARTY INSPECTION PROGRAM, which will allow device manufacturers to hire agency-approved "accredited persons" (APs) to perform FDA quality systems inspections, is progressing slowly as APs continue to undergo training. A dearth of device firms volunteering to host qualifying audits is largely to blame, FDA says, but the agency’s approach to managing the training process also appears to be causing delays. The National Electrical Manufacturers Association urges members to step forward for joint FDA/AP training audits, viewing the new program as a crucial means of advancing worldwide acceptance of the concept of third-party inspections

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