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AFRO/MEDICAL DEVICE HACCP TRAINING PROGRAM DOMESTIC COURSE REGISTRATION FORM/PROTOCOL Submit this form with the requested documentation to the Association of Food and Drug Officials, 2550 Kingston
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AFDO Medical Device HACCP (Hazard Analysis and Critical Control Point) is a system designed to ensure the safety of medical devices by identifying and controlling potential hazards.
All manufacturers and distributors of medical devices are required to file AFDO Medical Device HACCP.
To fill out AFDO Medical Device HACCP, manufacturers and distributors should follow the guidelines and instructions provided by AFDO (Association of Food and Drug Officials). These guidelines include conducting a hazard analysis, identifying critical control points, establishing critical limits, implementing monitoring procedures, and maintaining proper recordkeeping.
The purpose of AFDO Medical Device HACCP is to ensure the safety and effectiveness of medical devices by proactively identifying and controlling potential hazards throughout their lifecycle, from manufacturing to distribution.
AFDO Medical Device HACCP requires manufacturers and distributors to report detailed information about the hazard analysis, critical control points, critical limits, monitoring procedures, corrective actions, and verification procedures implemented to control potential hazards.
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