Webinar Details

FDA Enforcement in 2018-2019: Reading the Tea Leaves

Previously Recorded on January 24, 2018

This one-hour webinar will review and bring you up to date on:

  • Recent FDA enforcement trends for device and pharma firms – what can we expect?
  • Data integrity enforcement – how FDA is expanding this beyond pharma to CDRH and CVM
  • Where FDA is on their rollout of the new inspection methodologies NIPP and MDSAP
  • How the FDA-EU inspection cooperation program is supposed to work
  • Rapid review of FDA’s complete overhaul of its organizational structure and policies
  • Cybersecurity, 3D printing, and software-as-a-medical-device (SaaMD) – FDA’s progress to date and expectations for the next 12-18 months

At the end of this webinar, you should be able to better judge your risks and your strengths in 2018.

John AvellanetJohn Avellanet has trained FDA and Health Canada inspectors, served on behalf of the US Department of Justice as the independent overseer for a corporate integrity agreement, and was the industry expert reviewer for the international standard, BS 10008 Evidential Weight and Legal Admissibility of Electronic Information (2015).  He is the managing director and principal of Cerulean Associates LLC.


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