Publications & Presentations
August 9, 2017
Speaker Announcement: Using the CDRH’s Quality Initiative to Improve Your Bottom Line

Wednesday, August 9, 2017 | 1:30 pm - 3:00 pm ET

Polsinelli is proud to announce that Shareholder Michael M. Gaba is a featured speaker in FDANews' upcoming webinar on the Center for Devices and Radiological Health (CDRH) and its recent quality initiative. CDRH’s role as collaborator versus enforcer continues to evolve as Director Shuren sees the Center’s mission to improve the quality of medical devices for the benefit of patients as one requiring more collaboration with industry. By developing robust quality and compliance systems with CDRH’s input, industry can reduce its time and money spent on inspections, 483s, warning letters, and additional voluntary compliance efforts.

Michael will expand on the CDRH mindset, which is focused on quality improvement through transparency and compliance. Important topics covered include:
  • Missteps that trigger warning letters and 483s
  • How to use CDRH compliance data to improve inspection outcomes
  • How to boost manufacturing quality using CDRH compliance data
  • How to sift the raw numbers for gold — key data and statistical trends
  • Compliance strategies to avoid post-inspection escalation

Additional information and registration are available here.