ASQ Northern California Biomedical Discussion Group

JULY ROUNDTABLE EVENT – Register Now :

“FDA Medical Device Inspections: What To Expect During an FDA Medical Device Quality Systems Inspection and How to Prepare for The Inspection.”

Wednesday, July 24, 2019, 7-9PM, Stellartech-Milpitas, CA

Roundtable provides a view of what to expect when a medical device manufacturer receives notification of an FDA quality system inspection and suggestions for policies that can expedite inspections with more favorable outcomes. Having foresight into what topics/questions/records are typically covered during an FDA inspection helps a manufacturer to be better prepared for expediting the inspection and minimizing the number deficiencies the investigator may find, i.e.: FDA483 Inspectional Observations. Depending on the device, the inspection can cover FDA regulation sections §803, 806, 820, and 1000-1040. The seminar will also cover some FDA-483 Inspectional Observations.

FEATURED SPEAKER: Frank Eng worked 42 years as an FDA investigator, specializing in medical devices and laser products. Frank is well known in Silicon Valley as a fair and respected investigator.

Registration Link: ncdgjul2019.eventbrite.com

Event Information

Event Topic:
“FDA Medical Device Inspections: What To Expect During a FDA Medical Device Quality Systems Inspection and How to Prepare for The Inspection.”

Event Description:

Date/Time:
Date(s) - 07/24/19
7:00 pm - 9:00 pm

Event Location:
Other:

Event Details

Event Type