Quality Management Maturity - Do you Understand Your Site Risk Profile?

There has been much talk in recent weeks about FDA/CDER’s Quality Management Maturity announcement.

To increase transparency and incentivize investment in pharmaceutical manufacturing, FDA’s Office of Pharmaceutical Quality (OPQ) is now developing a framework to objectively rate the Quality Management Maturity of pharmaceutical manufacturing sites.

The research team at TU Dublin and St. Gallen University are proud to be involved in the research that is shaping the current thinking and in actively facilitating dialogue and publications between trade associations, academics, and regulators.

This week in TU Dublin we will share insights from our current FDA research project on establishing?a Risk Surveillance Model?(RiskSurv) for FDA to assist them in their risk-based site inspection planning. This is a burning hot issue for the regulators and industry and what we propose to share is hot off the press!

There will be discussions on managing risk in the manufacturing and third-party support network, including:

?How robust is your site risk surveillance program?

?Do you understand how regulators perceive your site Risk Profile - Is there a gap??

?How proactively do you manage the aspects that can impact your site Risk Profile?

The last few remaining places for this workshop are available with confirmation of attendees from WHO and HPRA, don’t miss the opportunity to join us. Contact [email protected] for late registration.