The last few months have seen a sharp change in the FDA’s enforcement power. Under its recent organizational changes, FDA is developing specific action plans to align its centers and the Office of Regulatory Affairs with new strategic goals and increased demands. Plus, the “Live Review” during an inspection has become more commonplace. Now an investigator will ask to “Live Review” the documents and data maintained in your QMS.
Today’s inspectors are a breed unto themselves — many have worked in industry and know where traps are hiding in your plant or its documentation. They are highly educated, clear-headed and are well trained to look into every aspect of your operations.
Take this rare opportunity to pick FDA investigators’ brains — how they think and what they look for.
Over two days, you’ll discover solutions to the sort of problems that keep you up at night —
- The new modern record review technique during an inspection…
- A day in the life of an FDA field investigator: Current and former investigators explain what they look for — and why — and what’s on the horizon …
- Quality metrics and the impact on your bottom line …
- The priorities of the ORA’s Office of Enforcement …
Plus, with twin tracks for drug/biologics and device manufacturers, you’ll discover sessions and panels for every FDA-regulated company.
- For drug and biologics makers, we’ve scheduled a standout panel on understanding OPQ’s new inspection and reporting plan and organizational structure as well as the quality-driven data integrity approach in the EU and US inspections.
- Devicemakers will hear first-hand progress on the Medical Device Single Audit Program from the FDA’s Marc-Henri Winter, who will share lessons learned from the pilot program. Devicemakers will learn what to expect from an audit and how multiple sites should be audited. Plus, an update from the Office of Compliance at CDRH and what their priorities are for 2017.
Listen to What Your Colleagues Have to Say About the FDA Inspections Summit.
Testimonials From Past Attendees:
– Dan Lewis, Site Quality Leader, P&G
– Nancy Carranza, Vice President, Operations, GSMS, Inc.
– Johanna Stamates, Executive Director - Research Compliance
and Quality Assurance, University of Miami
– Thomas Hoffman, Compliance, Medtronic