Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Corrective Actions Must Be Applied Systemically, FDA Warns Manufacturers

This article was originally published in The Silver Sheet

Executive Summary

CORRECTIVE ACTIONS STEMMING FROM FAILURE INVESTIGATIONS must be applied systemically across a manufacturer's organization, FDA says. "Go beyond the immediate correction of the issue or the nonconformance, which means going beyond the product," says FDA/GMP quality systems expert Kim Trautman. "Get to the processes and the systems that may have allowed a certain practice or incident to happen." Trautman says the agency isn't particularly concerned about which tools or techniques a firm uses during a failure investigation; rather, FDA investigators will focus on the entire investigation report when conducting a facility inspection. Meanwhile, device manufacturers Philips Medical Systems, Covidien, Hitachi Chemical Diagnostics and NeuroWave explain how they perform failure investigations and reveal how investigations can help a company save time and money. Experts also discuss when a failure investigation should be elevated to the CAPA system
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036369

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel