RAPS Texas Chapter: Current Trends in FDA Inspections

12 November 2015
6:00–8:00 pm
Emergo Group Headquarters
Austin

The Food and Drug Administration (FDA) inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. A good understanding of the inspection process can be critical to medical device manufacturers. Come join regulatory colleagues from your region to hear an expert presentation summarizing developments and recent trends in the FDA inspections.

Industry practice is driving change to FDA inspections and is causing the 15 year old Quality System Inspection Technique (QSIT) inspection methodology to vary from district to district. This presentation will examine the QSIT method and summarize current inspections trends that will assist medical device manufacturers prepare for their own inspections. The speaker will also provide proven, non-confrontational preparation methods that can help minimize the overall time FDA is onsite.

Free parking is in the building. Light refreshments will be available. Attendees who hold the RAC may claim 1.5 RAC recertification credits.

This meeting is sponsored by the RAPS Texas Chapter to promote knowledge advancement and facilitate networking among local regulatory professionals.