New York/New Jersey Chapter: The Ins and Outs of FDA Sponsor-Monitor Inspections

When:  Oct 18, 2018 from 5:30 PM to 8:30 PM

Thursday, 18 October 2018
5:30-8:30 pm EDT
Ferring Pharmaceuticals
100 Interpace Parkway
Parisippany, NJ 07054
+1 973 796 1600


The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm's compliance with applicable laws and regulations. This typically involves an investigator visiting a firm’s location. A single inspection may include multiple activities, which makes it imperative for regulatory professionals to understand the process and become familiar with the classifications.

Come join others from your local regulatory community for an evening of networking and a presentation followed by an interactive question and answer session. Topics to be covered will include:

  • History and purpose of BIMO inspections
  • Objectives of FDA sponsor-monitor inspections
  • FDA inspections statistics
  • Common findings from FDA inspections
  • Tips for hosting an FDA inspection
  • Case studies

The engagement activity, hosted by Ferring Pharmaceuticals, is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Light refreshments will be available to all attendees and RAC holders may claim two RAC recertification credits


Featured speaker:
Michael A. Trapani, MS, MBA, group leader, senior consultant, Biologics Consulting


Registration Information:
Prior to 11 October:
RAPS Member:  $35
Nonmember:  $50

On or After 11 October:
RAPS Member:  $45
Nonmember: $60


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Location

100 Interpace Pkwy
Parsippany, NJ 07054-1149