CDRH to promote risk-assessment priorities at Medical Device Quality Congress
The FDA's Center for Devices and Radiological Health (CDRH) is continuing its efforts to use information from other healthcare regulators to enhance its risk assessments of manufacturing facilities.
According to FDA News, Timothy Ulatowski, director of CDRH’s Office of Compliance, will detail the center’s priorities, including its work to recalibrate the FDA’s Office of Regulatory Affairs risk-based surveillance priorities, at the upcoming annual Medical Device Quality Congress this week in Cambridge, Mass.
Ulatowski will outline the FDA’s medical device facility inspections program and advise manufacturers of situations when they might be audited. Also at the conference, Steven Niedelman, vice president of Quintiles Consulting and former FDA deputy associate commissioner for regulatory operations, will discuss how firms can best operate supplier control programs while explaining the importance of tight agreements with contractors and the ways quality systems regulations address procurement issues.
Additionally, Julie Fraser, president of IT consultancy Cambashi, will present results from a survey of devicemakers on best practices for risk management. The survey found that investments in design controls and root cause analysis are the top areas companies focus on to reduce business risk, reported FDA News.
According to FDA News, Timothy Ulatowski, director of CDRH’s Office of Compliance, will detail the center’s priorities, including its work to recalibrate the FDA’s Office of Regulatory Affairs risk-based surveillance priorities, at the upcoming annual Medical Device Quality Congress this week in Cambridge, Mass.
Ulatowski will outline the FDA’s medical device facility inspections program and advise manufacturers of situations when they might be audited. Also at the conference, Steven Niedelman, vice president of Quintiles Consulting and former FDA deputy associate commissioner for regulatory operations, will discuss how firms can best operate supplier control programs while explaining the importance of tight agreements with contractors and the ways quality systems regulations address procurement issues.
Additionally, Julie Fraser, president of IT consultancy Cambashi, will present results from a survey of devicemakers on best practices for risk management. The survey found that investments in design controls and root cause analysis are the top areas companies focus on to reduce business risk, reported FDA News.