FDA Medical Device Inspections – Expectations and Audit Findings 1525
FDA Medical Device Inspections – Expectations and Audit Findings
5

Speaker

William Shackelford is a Consumer Safety Officer investigator with the U.S. Food and Drug Administration located in the Austin Resident Post in Austin, Texas.  He conducts medical device inspections and investigations for Division 3 of the Office of Medical Devices and Radiological Health Operations West to determine a firm’s compliance with the Quality System Regulation and other medical device regulations.  He has been with the FDA since 2009 performing original medical device submissions review, device compliance monitoring, and recalls review with the Center for Devices and Radiological Health (CDRH), and recently performing medical device investigative work in field operations for the Office of Regulatory Affairs (ORA).  Prior to joining FDA, he worked in the medical device diagnostics industry from 1980 to 2009 developing in-vitro diagnostic devices (IVDs) for the marketplace.  He holds a Master of Science in Biotechnology, a Bachelor of Science in Biology, a US Regulatory Affairs Certification (RAC), and an ASQ-CQIA certification.

Topic

FDA’s basic strategy for a typical medical device inspection from the viewpoint of an investigator, discussion on the regulations involved in a typical medical device inspection, and typical audit findings as far as the most frequent, and the most important from FDA’s perspective. Discussion on building quality aspects into medical devices, and how the FDA looks for this during inspections.
 

Venue
National Instruments

Address
11500 N Mopac Expy
Building C – Room 1s13/14/15
Austin, TX 78759

Schedule
6:00 – 6:30 PM – Networking Time/ Snacks
6:30 – 6:45 PM – Announcements
6:45 – 7:45 PM – Talk
7:45 – 8:00 PM – Door Prizes

Registration Please register here!

RU’s
0.5 RU’s will be awarded to ASQ members for attendance

Date & Time
Wednesday February 12th, 2020 6:00pm CST
End Date & Time
Wednesday February 12th, 2020 8:00pm CST
Venue
National Instruments
Address
11500 N Mopac Expressway
Building C – Room 1s13/14/15
Austin, TX 78759
United States
Category Public Calendar

Event Map

Date & Time: 02/12/2020 06:00:00 PM CST