Responding to FDA 483’s and Warning Letters
Following on nicely from Dr Fabricant, attendees will get guidance from Marc Ullman, partner at Ullman, Shapiro & Ullman LLP, and Dean Cirotta, president and COO at EAS Consulting Group LLC, on achieving regulatory compliance regarding FDA inspection findings (above), and how to properly address any stated observations and minimize the risk of further escalated responses from FDA.
Date & Time: Thursday, November 14, 10-10:50am